BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE X-TRACT MORCELLATOR

    MDR report key: 1203296 · Received October 14, 2008

    Report

    Report Number
    2210968-2008-00963
    Event Type
    Malfunction
    Date Received
    October 14, 2008
    Date of Event
    September 10, 2008
    Report Date
    September 11, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    HET
    PMA / PMN Number
    K993801
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (DEVICE WILL NOT RESTART) - CONCLUSION CODE: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVAL. THE EVAL FOUND THAT A DISPOSABLE HAND PIECE ATTACHED TO UNIT WITH NO DIFFICULTY AND THAT THE BLADE WOULD ROTATE IN BOTH DIRECTIONS AND AT ALL SPEED LEVELS WITHOUT STOPPING OR SLOWING DOWN. NO INTERNAL DAMAGE WAS FOUND AND THE POWER SUPPLY OUTPUT AND MOTOR PERFORMANCE WERE TO SPEC. IN ADDITION, A REVIEW OF THE DEVICE MFG RECORDS WAS CONDUCTED AND THE DEVICE MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A GYNECOLOGICAL PROCEDURE, DURING TESTING OF THE DEVICE, THE LIGHTS WENT OUT. THE UNIT WAS SHUT OFF AND TRIED AGAIN. THE UNIT STARTED UP BRIEFLY AND AGAIN LOST POWER, AND THEN IT WOULD NOT RESTART. A SECOND DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO ADVERSE PT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE X-TRACT MORCELLATOR LAPAROSCOPIC MORCELLATOR HET ETHICON, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK