BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE MORCELLEX TISSUE MORCELLATOR

    MDR report key: 1483244 · Received July 20, 2009

    Report

    Report Number
    2210968-2009-00807
    Event Type
    Malfunction
    Date Received
    July 20, 2009
    Date of Event
    June 18, 2009
    Report Date
    June 19, 2009
    Manufacturer
    ETHICON, INC.
    Product Code
    HET
    PMA / PMN Number
    K061050
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). BLADE DOES NOT CUT. CONCLUSION: 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. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. THIS IS ONE OF FIVE MEDWATCHES BEING SUBMITTED AS FIVE DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2009-00806, MEDWATCH 2210968-2009-00808, MEDWATCH 2210968-2009-00809 AND MEDWATCH 221098-2009-00810. 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 PROCEDURE ON (B) (6) 2009. DURING THE PROCEDURE, AFTER A FEW MINUTES OF USAGE, THE DEVICE MADE A GRINDING SOUND AND THE BLADE WOULD NOT CUT THROUGH ANY TISSUE. ANOTHER HANDPIECE WAS USED TO CONTINUE 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 MT212776

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK