10-1072

Organization name

AprioMed AB

SRN

SE-MF-000001013

Manufacturer status

Active

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

• CW999

  Precaution 1: The Bonopty® Coaxial Bone Biopsy System with Eccentric Drill should be used only by or under the supervision of a physician trained in biopsy or radiological interventions
• CW999

  When using devices from other manufacturers, first check the compatibility (length and gauge) of the tool with the Bonopty® components
• CW999

  Use finger force only during the biopsy procedure. Do not use extra tools to manipulate the components of the Bonopty® System.
• CW011

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.
• CW001

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.
• CW999

  Precaution 2: Carefully inspect the contents of the system prior to use to verify that all parts are present and undamaged
• CW999

  Precaution 3: The Bonopty® System is designed for single patient use only. After one use, components of the system may become dull or damaged, making a biopsy more difficult and less successful.
• CW999

  Precaution 6: During drilling, do not push the Cannula forward over the Drill, this hinder the ”wobbling” movement of the eccentric Drill and prevent the transportation of bone material out from the hole
• CW999

  Precaution 4: Be careful not to bend the components of the Bonopty® System during manipulation
• CW999

  Precaution 5: Contaminated products should be disposed utilizing standard hospital procedures for biohazardous waste
• CW999

  Bonopty is intended for use in image-guided procedures only. Verify the device location using imaging techniques after every device adjustment. Do not use Bonopty in Magnetic Resonance Imaging (MRI) equipment. The device is magnetic and exposure to MRI may cause unintended device movement.
• CW027

  EUDAMED did not publish a description for this code.
• CW999

  CONTRAINDICATIONS The Bonopty® Coaxial Bone Biopsy System with Eccentric Drill is contraindicated for use on patients who are receiving heavy anticoagulant therapy or who have a severe bleeding problem.
• CW999

  Not suitable for very sclerotic or purely lytic lesions. If a target or trajectory proves to be too hard to sample or penetrate using the Bonopty® Biopsy Cannula, stop the procedure and remove the Cannula. It may be possible to sample using the Bonopty® Extended Drill instead
• CW999

  The Penetration Cannula is designed for anchorage, and is not intended for passage through thick intact cortical bone
• CW999

  When the procedure is completed, do not remove the cannula without the support of the stylet or drill. Otherwise there is a risk that the cannula may break and part of it remains in the bone.

Primary placement in Sweden; available across 32 countries total.

Trade name

not provided

UDI-DI code

07350031350258

Basic UDI-DI

73500313511KG

Reference / catalog number

10-1072

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

https://apriomed.com/wp-content/uploads/29610.pdf

Clinical sizes

• 14
• 9.5 MU10

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

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

• A0102010101SHEARING BIOPSY NEEDLES