BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE X-TRACT MOTOR DRIVE UNIT

    MDR report key: 3242754 · Received July 23, 2013

    Report

    Report Number
    2210968-2013-14150
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    July 8, 2013
    Report Date
    July 8, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    HET
    PMA / PMN Number
    K993801
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY ON (B)(6) 2013. DURING THE PROCEDURE, THE DEVICE WOULD NOT ACTIVATE. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342641 GYNECARE X-TRACT MOTOR DRIVE UNIT LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) HET ETHICON INC. UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1