BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE X-TRACT MORCELLATOR

    MDR report key: 2212173 · Received August 15, 2011

    Report

    Report Number
    2210968-2011-01101
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 26, 2011
    Manufacturer
    ETHICON INC.
    Product Code
    HET
    PMA / PMN Number
    K100280
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PHYSICIAN USED TWO DIFFERENT DISPOSABLES AND THE MDU COULD NOT ACTIVATE EITHER DISPOSABLE. WITH THE FIRST DISPOSABLE, THE LIGHTS ON THE MDU WORKED BUT THE DISPOSABLE DID NOT WORK. WITH THE SECOND DISPOSABLE, THE TRIGGER WAS PULLED BUT DISPOSABLE DID NOT WORK. THE PROCEDURE WAS COMPLETED, BUT IT IS NOT KNOWN HOW IT WAS COMPLETED. CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY AND FUNCTIONALLY EVALUATED. THE REPORTED SYMPTOM WAS DUPLICATED. THE CAUSE WAS DUE TO A DAMAGED SET SCREW.

    Additional Manufacturer Narrative · 1

    (B)(4). INSUFFICIENT DRIVE OF DISPOSABLE. CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. 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 WHILE PREPARING TO PERFORM A CASE ON (B)(6) 2011 THE MOTOR DRIVE UNIT EXPERIENCED A CLICKING NOISE WITH THE DISPOSABLE HANDPIECE ATTACHED AND IT WOULD NOT ROTATE THE DEVICE. THERE WERE 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