BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS HAND CONTROLLED CURVED SHEA

    MDR report key: 1080515 · Received July 24, 2008

    Report

    Report Number
    3005075853-2008-00421
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Report Date
    June 18, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K002981
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 07/11/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP SIGMA PROCEDURE, THE HAND ACTIVATION KNOB DID NOT FUNCTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PT CONSEQUENCE. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HS HAND CONTROLLED CURVED SHEA NONE GEI ETHICON ENDO-SURGERY, LLC NA D4JN0M

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR| HANDPIECE