BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE X-TRACT MORCELLATOR

    MDR report key: 1003315 · Received February 27, 2008

    Report

    Report Number
    2210968-2008-00113
    Event Type
    Malfunction
    Date Received
    February 27, 2008
    Date of Event
    January 28, 2008
    Report Date
    January 28, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    HET
    PMA / PMN Number
    K993801
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. 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 A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN 2008. DURING THE PROCEDURE, WHILE REMOVING A LARGE FIBROID UTERUS, THE MOTOR DRIVE UNIT WAS SHUTTING DOWN. THE SURGEON WAITED AND THEN RESTARTED THE DEVICE AND SAME EVENT REOCCURRED. THREE DISPOSABLE HAND PIECES WERE ATTEMPTED, AND THE CASE WAS UNABLE TO BE COMPLETED. THE SURGEON OPINES THAT THE MOTOR DRIVE UNIT WAS NOT POWERFUL ENOUGH TO DRIVE THE DISPOSABLE HAND PIECES. A DIFFERENT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH 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 UNK