Organization name

LSI SOLUTIONS, Inc.

SRN

US-MF-000008267

Manufacturer status

Active

5 warnings recorded — scroll inside the panel to see all entries.

• CONTRAINDICATIONS • The SEW-EASY® SYSTEM is not intended to be used with any suture other than a RAM® COR-SUTURE ® QUICK LOAD® suture in conjunction with a RAM® Suturing Device. • Do not use this suture under conditions in which excessive suture tension can lead to tissue damage.

  OTHER

• WARNINGS • Endoscopic or minimally invasive procedures should only be performed by physicians having adequate training and familiarity with associated techniques. In addition, medical literature should be consulted relative to techniques, complications and hazards prior to the performance of such procedures. • Federal law restricts this device to sale, distribution and use by, or on, the order of a physician. • As with any foreign body, prolonged contact of any suture with salt solutions, such as those found in the urinary or biliary tracts, may result in calculus formation. • Do not resterilize. The SEW-EASY® DEVICE is designed and intended for single patient use only. Do not reuse, reprocess, or resterilize this product. The performance of the SEW-EASY® DEVICE after cleaning or other reprocessing has not been verified and is not supported by LSI Solutions, Inc. Reuse, reprocessing, or resterilization may compromise the integrity of the device and/or create a risk of contamination of the device, which could result in patient injury, illness, or death. • Discard open (unsealed), unused, expired or damaged devices, or devices in damaged primary packaging. • Store at room temperature. Avoid prolonged exposure to elevated temperatures. • Users should be familiar with surgical procedures and techniques involving surgical suture before employing the SEW-EASY® SYSTEM, as risks may vary with the site of application and the suture material used. Proper orientation of the prosthesis is required. Avoid crossing or twisting suture. • Acceptable surgical practice must be followed with respect to drainage and closure of contaminated or infected wounds.

  OTHER

• WARNINGS • Redundant, cut-away suture remnants, used needle caps, SEW-EASY® Cassettes, and SEW-EASY® Devices, along with packaging, must be inspected, handled and disposed of consistent with standard, accepted medical device disposal procedures. • The SEW-EASY® SYSTEM used in conjunction with RAM® COR-SUTURE ® QUICK LOAD® suture is not for use in neurological procedures. • Applications other than for soft tissue approximation, or to approximate soft tissue and prosthetic materials, can result in failure to pick up suture or in damage to the device making it unsuitable for continued use. • Never drive the needles into suture, pledgets, bone, dense ligamentous tissue, calcific tissue, metal features, stents, struts, components or other instruments. • Do not leave any foreign material (e.g. suture remnant, needle cap, etc.) unattached in areas potentially exposed to circulating blood. • If securing the RAM® COR-SUTURE ® QUICK LOAD® suture with any LSI SOLUTIONS® COR-KNOT® DEVICE (COR-KNOT® MIS DEVICE, COR-KNOT MINI® DEVICE), ensure any needle caps are removed from the suture ends being loaded, prior to loading the suture through the COR-KNOT® DEVICE. • The SEW-EASY® DEVICE is not intended for use in prosthetic materials through which the device needles cannot readily penetrate, based on the surgeon's judgment. • The SEW-EASY® valve handles are not intended for use with prosthetic valves with which the valve handle does not readily connect.

  OTHER

• PRECAUTIONS • After each loading and re-loading of a new suture into a cassette, carefully inspect that the new needle caps are fully seated in the needle cap compartment. If the needle caps are not fully seated in the needle cap compartment, damage to the needles or needle caps may result, including fracturing off of the tips of the needles. • Do not use the SEW-EASY® SYSTEM to dissect or aggressively manipulate tissue structures. • Verify that the needle caps are still retained within the needle cap compartments and the device has not been damaged or deformed before attempting to place a stitch. • Do not manipulate the device at any time with the pink lever partially actuated. This may expose sharp surfaces that can cause trauma to the patient, the prosthesis, the device operator or other staff, or damage the device. • Ensure the advancing needles target and enter the needle cap compartment. For example, during the suture placement, avoid using an extended needle to manipulate or lift tissue or prosthetic because such an action can cause the needle to deviate from its targeted course toward the needle caps compartment. A needle tip not entering the needle cap compartment properly can strike the cassette tip of the device and lead to undesired outcomes, including needle tip fracture, missed needle cap, or non-needle cap pickup.

  OTHER

• PRECAUTIONS • Check for hemostasis where appropriate. • The SEW-EASY® SYSTEM will not fit through standard laparoscopic cannulas with seals. • Before endoscopic instruments and accessories from different manufacturers are employed together in a procedure, verify compatibility and ensure that electrical isolation or grounding is not compromised. • Ensure 3.5mm SEW-EASY® Cassettes are used only with 3.5mm SEW-EASY® Devices and 3.5mm RAM® Devices. Similarly, ensure 5mm SEW-EASY® Cassettes are used only with 5mm SEW-EASY® Devices and 5mm RAM® Devices. • Always assure cassette tip is viewed under direct visualization before advancing the needle. • Ensure that obstructions do not interfere with the firing of the SEW-EASY® SYSTEM; obstruction may cause damage to the needles. • If the prosthetic sewing cuff does not readily release from the cassette jaw, or the cassette does not readily release from the device, ensure pink lever is fully released. • Do not squeeze the pink lever of the SEW-EASY® SYSTEM while loading a RAM® COR-SUTURE ® QUICK LOAD® suture; squeezing the pink lever may expose the sharp needles and/or damage the needles. • In handling the SEW-EASY® SYSTEM, care should be taken to avoid jamming the suture into the needle cap compartment which can damage the needles. • Avoid damage to the needles, suture or needle caps due to direct application of surgical instruments, like forceps, needle holders, clamps, etc. • Adequate knot security requires accurate completion of accepted surgical techniques for constructing surgically tied knots or the use of the COR-KNOT® MIS DEVICE, COR-KNOT MINI® DEVICE, and COR-KNOT® QUICK LOAD® DEVICE or INTRA-KNOT® QUICK LOAD® as warranted by surgical circumstances and the experience of the surgeon.

  OTHER

Primary placement in Netherlands; available across 32 countries total.

Trade name

SEW-EASY® 3.5mm COMBO KIT

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

00850200006506

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

0850200006SEW-EASY68

Reference / catalog number

00850200006506

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

The SEW-EASY® Device is a disposable single-use device, used in conjunction with removable single-use dual needle-carrying SEW-EASY® cassettes. The SEW-EASY® cassettes are attached to the SEW-EASY® DEVICE one at a time. The LSI SEW-EASY® Product Family Consists of the SEW-EASY® Device Kit containing a single device, Combo Kit that includes a device and 12 cassettes, and individually packaged Cassettes Singles. The Device and Combo Kits also include four valve handles with different connection types intended to be compatible with various valve models from different manufacturers.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• H9099SUTURE DEVICES - OTHER

• Class I medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.

Certificate health across this manufacturer's portfolio.