BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHOR TISSUE RETRIEVAL SYSTEM

    MDR report key: 2250756 · Received September 2, 2011

    Report

    Report Number
    2250756
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 3, 2011
    Report Date
    September 2, 2011
    Manufacturer
    ANCHOR SURGICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE PREPARING DISPOSABLE INSTRUMENT FOR INSERTION INTO PATIENT, INSTUMENT MALFUNCTIONED AND BROKE. THIS WAS NOTED BEFORE USE ON THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANCHOR TISSUE RETRIEVAL SYSTEM NEW-ANCHOR TISSUE RETRIEVAL SYSTEM GCJ ANCHOR SURGICAL REF# TRS100SB2 SO2N

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR