BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE X-TRACT MOTOR DRIVE UNIT

    MDR report key: 3212479 · Received July 9, 2013

    Report

    Report Number
    2210968-2013-12540
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Report Date
    June 20, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    HET
    PMA / PMN Number
    K993801
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 LAPAROSCOPIC HYSTERECTOMY ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE DEVICE WAS NOT PROVIDING ENOUGH POWER TO THE HANDPIECE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITH NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313006 GYNECARE X-TRACT MOTOR DRIVE UNIT LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) HET ETHICON INC. UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1