BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE X-TRACT MORCELLATOR

    MDR report key: 2801693 · Received October 23, 2012

    Report

    Report Number
    2210968-2012-00137
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Report Date
    October 1, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    HET
    PMA / PMN Number
    K993801
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY AND FUNCTIONALLY EVALUATED. UPON EVALUATION, THE UNIT HAD TWO LOOSE LID SCREWS AND TWO MISSING. THE UNIT HAD MISSING TWO RUBBER FEET AND ONE WAS A NON MANUFACTURED RUBBER FOOT. THE CPC CONNECTOR AND FRONT WASHER WERE MISSING. EVALUATION FOUND THAT UNIT WOULD NOT CHANGE SPEEDS WHICH WAS DUE TO A DEFECTIVE MEMBRANE OVERLAY.

    Additional Manufacturer Narrative · 1

    (B)(4). DAMAGE TO DRIVE CONNECTOR OR COUPLING. CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. 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 THE FRONT CONNECTOR ON THE MOTOR DRIVE UNIT WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT AND 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