BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SONIX

    MDR report key: 259118 · Received January 17, 2000

    Report

    Report Number
    MW1017949
    Event Type
    Malfunction
    Date Received
    January 17, 2000
    Date of Event
    January 11, 2000
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING USE, TIP OF HARMONIC SCALPEL BLADE BROKE OFF IN PT. ONE PIECE RETRIEVED. TIP REMAINS: UNSEEN ON X-RAY. RESP STATUS STABLE AND INFECTION STATUS NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SONIX ULTRA SHEARS 5MM GCJ UNITED STATES SURGICAL CORP. ULTRA SHEARS U9J55

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other