BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 45 CM, CURVED SHEARS WITH ERGONOMIC HANDLE, HAND CONTROL AND

    MDR report key: 2190812 · Received July 29, 2011

    Report

    Report Number
    MW5021583
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 29, 2011
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING LAPAROSCOPIC SURGERY, HARMONIC INSTRUMENT CEASED TO FUNCTION. A NEW HANDPIECE WAS OBTAINED TO COMPLETE THE SURGICAL CASE. DURING INSPECTION OF THE MALFUNCTIONING HANDPIECE, IT WAS NOTED THAT ONE SCISSOR TIP WAS MISSING. A SEARCH RESULTED IN FINDING THE MISSING BLADE ON THE OPERATING ROOM FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 45 CM, CURVED SHEARS WITH ERGONOMIC HANDLE, HAND CONTROL AND HARMONIC ACE LFL ETHICON ENDO-SURGERY H4404N

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR