BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE X-TRACT MORCELLATOR

    MDR report key: 2943827 · Received February 5, 2013

    Report

    Report Number
    2210968-2013-00779
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Report Date
    January 16, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    HET
    PMA / PMN Number
    K993801
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): 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 TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-00780. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    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 GYNECOLOGICAL PROCEDURE. DURING THE PROCEDURE, THE DEVICE WOULD NOT DRIVE THE DISPOSABLE. ANOTHER LIKE DEVICE WAS USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47671 GYNECARE X-TRACT MORCELLATOR LAPAROSCOPIC MORCELLATOR HET ETHICON, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1