BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON

    MDR report key: 1891038 · Received October 28, 2010

    Report

    Report Number
    MW5017987
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 28, 2010
    Manufacturer
    STERILMED
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HARMONIC ACE WORKING END WAS LOOSE. UNABLE TO USE, NO HARM TO PT STERIL MED: PACKAGING WAS THROWN AWAY. CODE # ON DEVICE: (B)(4) NOTED STAMPED ON DEVICE 5 MM TROCAR: SEAL FAILED, LEAKED DURING CASE. NO HARM TO THE PT. PRODUCT PACKAGING WAS THROWN AWAY CODE # ON DEVICE: (B)(4) NOTED STAMPED ON DEVICE. DATES OF USE: (B)(6) 2010 - (B)(6) 2010. EVENT ABATED AFTER USE: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON HARMONIC ACE LFL STERILMED G9KJ86SM
    2 ETHICON TROCAR GCJ STERILMED F9HU811SM

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR