BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE X-TRACT MOTOR DRIVE UNIT

    MDR report key: 3833602 · Received May 27, 2014

    Report

    Report Number
    2210968-2014-06698
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Report Date
    July 10, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    HET
    PMA / PMN Number
    K993801
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 CPC CONNECTOR NEEDED TO BE REPLACED. IN ADDITION, THE OUTER HOUSING OF THE UNIT WAS HEAVILY DAMAGED RESULTING IN THE REPLACEMENT OF THE COVER, MEMBRANE PANEL, AND CHASSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE DEVICE WAS NOT FUNCTIONING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. UPON EVALUATION OF THE DEVICE, THE CPC CONNECTOR NEEDED TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310284 GYNECARE X-TRACT MOTOR DRIVE UNIT LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) HET ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1