BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE MORCELLEX TISSUE MORCELLATOR

    MDR report key: 1170345 · Received September 11, 2008

    Report

    Report Number
    2210968-2008-00801
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    August 5, 2008
    Report Date
    August 12, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    HET
    PMA / PMN Number
    K061050
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER: BLADE SEIZED/STOPPED - 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. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2008-00800. THE SAMPLE PATIENT 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 DEVICE SEIZED AND STOPPED ENTIRELY. THE SURGEON KEPT TRYING TO PUT THE DEVICE FORWARD AND BACKWARD AND THE DEVICE STILL WOULD NOT CONTINUE. THE PATIENT HAD A LARGE FIBROID UTERUS. ANOTHER SAME DEVICE WAS 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 MT211736

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK