Disposable Circular Stapler

Trade name

Disposable Circular Stapler

UDI-DI code

06954790910015

Basic UDI-DI

B-06954790910015

Reference / catalog number

TCYW-34

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

• H02020299CIRCULAR STAPLERS FOR OPEN SURGERY - OTHER

1 warning recorded — scroll inside the panel to see all entries.

• CW999

  1.The stapler is disposable and can be used after opening the sterile package. Once the package is found to be damaged, it must not be used. When in use, the sterile techique shall be strictly executed. 2.The stapler is sterilized by ethylene oxide, and is delivered in a sterile sealed package. The validity period is three years from the date of sterilization. Products beyond the validity period are strictly prohibited to use. 3.After the anastomosis, check the residual tissue of the cut nub. If there is a defect or leakage of the anastomosed tissue, several stitches shall be added to the corresponding part of the suture incision to ensure the quality of the anastomosis. 4.Anastomotic fistula is a common serious complication. It is mainly caused by uneven thickness around the tissue to be sutured, too much tissue left on the outer side of the pocket, inflammation of the anastomotic stoma, excessive tension of the anastomotic stoma, etc. Once it occurs, symptomatic treatment shall be performed. 5.Anastomotic stenosis: It is also a common complication after anastomosis. The main reason is that the anastomotic lip is wide and the number of staples is relatively small, resulting in poor anastomotic mucosal alignment, and abnormal growth of granulation tissue during the healing process, resulting in ring anastomotic stenosis. Once it occurs, symptomatic treatment shall be performed. 6.If there is blood oozing as the pocket is not uniformly made, symptomatic treatment shall be performed. 7.This instruction for use is only a general introduction to the use of the stapler, and is not for surgical guidance. The surgeon must refer to the relevant medical literature and related surgical atlas during the operation.

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