BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE X-TRACT MORCELLATOR

    MDR report key: 1082844 · Received July 24, 2008

    Report

    Report Number
    2210968-2008-00587
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 25, 2008
    Report Date
    June 25, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    HET
    PMA / PMN Number
    K993801
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 07/23/2008. (INSUFFICIENT DRIVE OF DISPOSABLE): CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. A DISPOSABLE HAND PIECE WAS ATTACHED TO UNIT WITH NO DIFFICULTY. THE BLADE ROTATED IN BOTH DIRECTIONS AND AT ALL SPEED LEVELS. THE MOTOR DRIVE NEVER STOPPED AND THE LIGHTS DID NOT FLASH. ALSO, THE 24VDC OUTPUT WAS CHECKED, A STALL TEST WAS PERFORMED, AND AN INTERNAL INVESTIGATION FOUND NO PROBLEMS. ALL TESTS CONFIRMED THE UNIT'S PROPER OPERATION. IN ADDITION, A REVIEW OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED AND THE DEVICE MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN 2008. DURING THE PROCEDURE, THE LIGHTS WERE FLASHING ON THE DEVICE. NO ADVERSE PATIENT CONSEQUENCES OCCURRED.

    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