BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE MORCELLEX TISSUE MORCELLATOR

    MDR report key: 956252 · Received November 30, 2007

    Report

    Report Number
    2210968-2007-01095
    Event Type
    Malfunction
    Date Received
    November 30, 2007
    Date of Event
    October 19, 2007
    Report Date
    November 1, 2007
    Manufacturer
    ETHICON, INC.
    Product Code
    HET
    PMA / PMN Number
    K061050
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 11/30/2007. 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. THIS IS ONE OF THREE MEDWATCHES BEING SUBMITTED AS THREE DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCHES 2210968-2007-001096, 2210968-2007-01097. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN 2007. DURING THE PROCEDURE, THE CUTTER WAS ROTATING BUT THE TISSUE EFFECT WAS NOT AS DESIRED AS IF THE CUTTER WAS DULLING. THE DEVICE WAS REPLACED WITH A SECOND DEVICE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED 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 MT210993

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR