BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE X-TRACT MOTOR DRIVE UNIT

    MDR report key: 3212718 · Received July 9, 2013

    Report

    Report Number
    2210968-2013-12550
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 25, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    HET
    PMA / PMN Number
    K993801
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - UNABLE TO ACTIVATE DISPOSABLE. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. IN ADDITION, A REVIEW OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED AND THE DEVICE MET ALL FINISHED GOODS RELEASE CRITERIA.

    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 DEVICE PASSED ALL FUNCTIONAL TESTS AND WAS FULLY OPERATIONAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC HYSTERECTOMY ON (B)(6) 2013. DURING THE PROCEDURE, THE DEVICE WOULD NOT ENGAGE WHEN THE TRIGGER WAS PULLED ON THE DISPOSABLE. THERE WAS NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313337 GYNECARE X-TRACT MOTOR DRIVE UNIT LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) HET ETHICON INC. UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR