BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACE LAPAROSCOPIC SHEARS

    MDR report key: 3893838 · Received June 18, 2014

    Report

    Report Number
    MW5036787
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 17, 2014
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AN ETHICON ENDO-SURGERY ACE LAPAROSCOPIC SHEARS WOULD NOT PASS THE INITIAL GENERATOR TEST. REASON FOR USE: LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358929 ACE LAPAROSCOPIC SHEARS HARMONIC SCALPEL, 5MM X 36CM LFL ETHICON ENDO-SURGERY HAR36 L90Y9C

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR