BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS HAND CONTROLLED CURVED SHEA

    MDR report key: 1190923 · Received October 9, 2008

    Report

    Report Number
    1527736-2008-03523
    Event Type
    Malfunction
    Date Received
    October 9, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 19, 2008
    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
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 06/05/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP GASTRIC BYPASS PROCEDURE, THE DEVICE WAS MAKING A FUNNY NOISE. THE DEVICE WAS PULLED OUT, WIPED OFF AND INSPECTED. IT WAS OBSERVED THAT THE BLADE HAD COME OFF. THE BLADE WAS RECOVERED FROM THE FLOOR. NO ADVERSE PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HS HAND CONTROLLED CURVED SHEA NONE GEI ETHICON ENDO SURGERY, INC. (CINCINNATI) NA E4KV76

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR