BEUDAMED
    FDA Adverse Event Other Summary report: N

    LINVATEC

    MDR report key: 105023 · Received July 1, 1997

    Report

    Report Number
    105023
    Event Type
    Other
    Date Received
    July 1, 1997
    Date of Event
    June 4, 1997
    Report Date
    June 5, 1997
    Manufacturer
    LINVATEC
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING ARTHROSCOPY OF THE SHOULDER APPROXIMATELY 1 MM OF THE CAUTERY TIP BROKE OFF. IT COULD NOT BE RETRIEVED FROM THE SURGICAL WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINVATEC ELECTRODE ACROMIOPLASTY GEI LINVATEC 980113 44459

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other