BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE X-TRACT MORCELLATOR

    MDR report key: 1060544 · Received June 12, 2008

    Report

    Report Number
    2210968-2008-00422
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 13, 2008
    Report Date
    May 14, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    HET
    PMA / PMN Number
    K993801
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSUFFICIENT DRIVE OF DISPOSABLE - CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE EVALUATION WAS UNABLE TO DUPLICATE THE CUSTOMER'S REPORTED SYMPTOM. THE EVALUATION VERIFIED THAT THE UNIT PERFORMS ACCORDING TO PROCEDURE. AT NO TIME DID THE DISPOSABLE STOP DRIVING OR DID THE MOTOR MAKE LOUD NOISES. THE POWER SUPPLY 24VDC OUTPUT WAS CHECKED AND A STALL TEST WAS PERFORMED PER TEST PROCEDURE. INTERNAL INSPECTION REVEALED NO LOOSE HARDWARE OR ELECTRICAL CONNECTIONS. THIS IS ONE OF THREE MEDWATCHES BEING SUBMITTED AS THREE DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2008-00423 AND MEDWATCH 2210968-2008-00424. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN 2008. DURING THE PROCEDURE, THE HAND PIECE BLADE WOULD NOT SPIN AND THE MOTOR DRIVE UNIT MADE LOUD NOISES. THE HAND PIECE WAS REPLACED AND THE SAME EVENT OCCURRED. A SECOND MOTOR DRIVE UNIT, AND A THIRD HAND PIECE WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT 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