BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE X-TRACT MORCELLATOR

    MDR report key: 1000677 · Received February 21, 2008

    Report

    Report Number
    2210968-2008-00093
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    January 21, 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
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 2/21/08, DAMAGE TO DRIVE CONNECTOR/ COUPLING, CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFO DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A LAPAROSCOPIC MYOMECTOMY IN 2008, WHILE ATTEMPTING TO CONNECT THE HAND PIECE TO THE MOTOR DRIVE UNIT, THE CPC CONNECTOR BROKE AWAY FROM THE MOTOR DRIVE UNIT. THIS OCCURRED BEFORE USE ON THE PT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY CUTTING THE MYOMA WITH SCISSORS INSIDE THE PELVIC CAVITY WITH NO ADVERSE PT CONSEQUENCES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK