BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE MORCELLEX TISSUE MORCELLATOR

    MDR report key: 1060543 · Received June 12, 2008

    Report

    Report Number
    2210968-2008-00423
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 13, 2008
    Report Date
    May 14, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    HET
    PMA / PMN Number
    K061050
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 06/12/2008. BLADE SEIZED/STOPPED - CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFO 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 2210968-2008-00422 AND MEDWATCH 2210968-2008-00424. THE SAME PT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN 2008. DURING THE PROCEDURE, THE HAND PIECE BLADE WORKED FOR A WHILE AND THEN STOPPED, AND THE MOTOR DRIVE UNIT MADE LOUD NOISES. A SECOND HAND PIECE AND A SECOND MOTOR DRIVE UNIT WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE MORCELLEX TISSUE MORCELLATOR LAPAROSCOPE, GYNECOLOGIC HET ETHICON, INC. NA MT210435

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK