BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE X-TRACT MORCELLATOR

    MDR report key: 1021841 · Received March 28, 2008

    Report

    Report Number
    2210968-2008-00198
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    February 27, 2008
    Report Date
    February 27, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    HET
    PMA / PMN Number
    K993801
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVAL. THE EVAL COULD NOT DUPLICATE THE REPORTED SYMPTOM. THE EVAL VERIFIED THAT THE STALL FEATURE WORKED PROPERLY, THE ALIGNMENT WAS GOOD, AND THE UNIT CYCLED PROPERLY IN BOTH DIRECTIONS AT LOW AND HIGH SPEEDS. 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 DID NOT SEEM TO BE ABLE TO DRIVE THE DISPOSABLE HAND PIECE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME MOTOR DRIVE UNIT 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