BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE MORCELLEX TISSUE MORCELLATOR

    MDR report key: 1861277 · Received October 1, 2010

    Report

    Report Number
    2210968-2010-01208
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 2, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    HET
    PMA / PMN Number
    K100280
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). BLADE SEIZED/STOPPED. CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVAL IS NOT YET COMPLETE. ANY FURTHER INFO DERIVED FROM THE EVAL WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. IN ADDITION, A REVIEW OF THE BATCH MFG RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. THIS IS ONE OF THREE MEDWATCHES BEING SUBMITTED AS THREE DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2010-01207, AND 2210968-2010-01209. THE SAME PT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY PROCEDURE ON (B)(6) 2010. WHILE USING THE DEVICE, THE SURGEON WAS SQUEEZING THE TRIGGER OF THE DEVICE AND THE BLADES WOULD NO LONGER ROTATE. ANOTHER LIKE DEVICE WAS OPENED AND USED. THERE WERE 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 MT213949

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK