BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS HAND CONTROLELD CURVED SHEA

    MDR report key: 1830343 · Received January 2, 2008

    Report

    Report Number
    1527736-2008-00020
    Event Type
    Malfunction
    Date Received
    January 2, 2008
    Date of Event
    December 7, 2007
    Report Date
    December 14, 2007
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    GEI
    PMA / PMN Number
    K002981
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP APPENDECTOMY, THE DEVICE WAS NOT RESPONDING TO THE HAND ACTIVATION BUTTONS. USED ANOTHER LIKE DEVICE TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HS HAND CONTROLELD CURVED SHEA GEI ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA D4JL70

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR| HANDPIECE