BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-FIX/IMPLANTS

    MDR report key: 1961568 · Received January 14, 2011

    Report

    Report Number
    1219602-2011-00012
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    September 28, 2010
    Report Date
    September 29, 2010
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE
    Product Code
    GAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THREE USED DEVICES WERE RETURNED. ALL THREE DEVICE WERE RETURNED WITH NO TS OR SUTURE ATTACHED. CONDITION OF THE DEVICES IS INCONSISTENT WITH NOT DEPLOYING. WITH THE INFORMATION PROVIDED AND THE PHYSICAL CONDITION OF THE RETURNED DEVICES IT CANNOT BE DETERMINED WHY THE USER EXPERIENCED THIS ISSUE. (B)(4).

    Description of Event or Problem · 1

    DURING THE CASE DR USED THREE OF THESE UNITS AND ALL THREE DID NOT DEPLOY THE 4TH ONE DID. DR IS FAMILIAR WITH THESE ITEMS AND KNOWS HOW TO USE THEM. IT IS UNKNOWN IF TS WAS LEFT IN PATIENT OR NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FAST-FIX/IMPLANTS FAST-FIX AB ASSY - CURVED GAT SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE 7209399 50343059

    Patients

    Seq Age Sex Outcome Treatment
    1