BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE

    MDR report key: 1904239 · Received November 17, 2010

    Report

    Report Number
    MW5018243
    Event Type
    Injury
    Date Received
    November 17, 2010
    Date of Event
    October 11, 2010
    Report Date
    November 5, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    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

    DEVICE TIP BROKE. NO INJURY TO PT. TYPE OF INTERVENTION: NEW DEVICE OBTAINED. DATES OF USE: (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: INGUINAL HERNIA. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE, HAND CONTROL AND TORQUE WRENCH (FOR USE WIT LFL ETHICON ENDO-SURGERY, LLC ACE36E G9L049

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention