BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE X-TRACT MORCELLATOR

    MDR report key: 1942485 · Received December 22, 2010

    Report

    Report Number
    2210968-2010-01724
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 24, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    HET
    PMA / PMN Number
    K993801
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - DAMAGE TO DRIVE CONNECTOR OR COUPLING. CONCLUSION CODE: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. THIS IS ONE OF THREE MEDWATCHES BEING SUBMITTED AS THREE DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2010-01722 AND 01723. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY ON (B)(6) 2010. A GRINDING NOISE WAS NOTED FROM THE BEGINNING OF THE PROCEDURE AND THEN THE MOTOR DRIVE UNIT TWISTED THE CABLE ON THE DISPOSABLE HANDPIECE. THE SURGEON WAS UNABLE TO REMOVE THE DISPOSABLE FROM THE MOTOR DRIVE UNIT. THE PATIENT'S INCISION WAS OPENED AND UTERUS WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE X-TRACT MORCELLATOR LAPAROSCOPE MORCELLATOR HET ETHICON, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention