BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE SHEARS, 5.5 DIA, ERG HANDLE, CURVED

    MDR report key: 3042675 · Received April 3, 2013

    Report

    Report Number
    MW5029639
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, INC
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    LOWER JAW OF HARMONIC ACE BROKE OFF IN PT'S ABDOMINAL CAVITY. LOWER JAW FOUND, AND REMOVED FROM PT. REASON FOR USE: LAPAROSCOPIC ROUX EN Y GASTRIC BYPASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136760 HARMONIC ACE SHEARS, 5.5 DIA, ERG HANDLE, CURVED HARMONIC SCALPEL LFL ETHICON ENDO-SURGERY, INC ACE36E 2367610

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention