BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON ENDO-SURGERY, LLC

    MDR report key: 1652396 · Received April 2, 2010

    Report

    Report Number
    MW5015423
    Event Type
    Malfunction
    Date Received
    April 2, 2010
    Date of Event
    March 30, 2010
    Report Date
    April 1, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    OPENED PRODUCT AND NOTICED TIP BROKEN OFF AND LAYING ON TOP OF SPONGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO-SURGERY, LLC HARMONIC ACE LFL ETHICON ENDO-SURGERY, LLC. F4PH18

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR