BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE X-TRACT MORCELLATOR

    MDR report key: 1000679 · Received February 21, 2008

    Report

    Report Number
    2210968-2008-00094
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    January 22, 2008
    Report Date
    January 22, 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

    DATE SENT TO THE FDA: 2/21/2008. CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. DURING EVALUATION, THE REPORTED SYMPTOMS WERE NOT DUPLICATED. USING A TEST FIXTURE HAND PIECE, THE UNIT RAN FOR FIFTEEN MINS CLOCKWISE AND COUNTER CLOCKWISE WITHOUT THE BLADE STALLING OR BLADE ROTATION PROBLEMS. INTERNAL INSPECTION REVEALED NO LOOSE HARDWARE OR ELECTRICAL CONNECTIONS. THE STALL TEST AND RPM MEASUREMENTS WERE PERFORMED PER REQUIREMENTS. 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 A PT UNDERWENT A GYNECOLOGICAL PROCEDURE IN 2008. DURING THE PROCEDURE, THE MOTOR DRIVE UNIT SEEMED TO STALL EASILY WHEN USED. THE BLADE WOULD NOT ROTATE SMOOTHLY BUT STARTED AND STOPPED INTERMITTENTLY. THE CASE WAS SUCCESSFULLY COMPLETED USING THE SAME DEVICE 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