BEUDAMED
    FDA Adverse Event Other Summary report: N

    GYNECARE MORECELLEX TISSUE MORCELLATOR

    MDR report key: 1731404 · Received June 17, 2010

    Report

    Report Number
    2210968-2010-00693
    Event Type
    Other
    Date Received
    June 17, 2010
    Date of Event
    May 17, 2010
    Report Date
    May 17, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    HET
    PMA / PMN Number
    K100280
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE ACTUAL DEVICE AND THE REDUCER CAP INVOLVED IN THIS EVENT WERE RETURNED FOR EVALUATION. UPON EXAMINATION OF THE REDUCER CAP, IT WAS DETERMINED THAT ONE OF THE FOUR "PROTECTORS" WAS MISSING FROM THE REDUCER CAP. THE REDUCER CAP WAS THEN DISMANTLED AND IT WAS CONFIRMED THAT ONE OF THE PROTECTORS WAS MISSING. THE DEVICE WAS ALSO DISASSEMBLED AND EXAMINED AND THERE WERE NO ABNORMALITIES NOTED. VISUAL EXAMINATION OF THE PHOTOGRAPHIC IMAGE TAKEN OF THE ACTUAL MISSING PROTECTOR WAS PERFORMED. ALTHOUGH NO DIRECT CONCLUSION CAN BE MADE FROM THE IMAGE, IT CAN BE DISCERNED THAT SOME SORT OF GRASPING INSTRUMENT MAY HAVE CONTACTED A REGION OF THE PROTECTOR. INVESTIGATION OF THE EVENT IS IN PROGRESS AND ADDITIONAL INFORMATION WILL BE PROVIDED AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010. DURING THE PROCEDURE, WHILE THE SURGEON WAS USING A GRASPER THROUGH THE DEVICE TO PICK UP PIECES OF THE UTERUS, A SMALL PLASTIC PIECE OF THE DEVICE FELL INTO THE ABDOMEN. THE SURGEON USED THE GRASPER TO SUCCESSFULLY RETRIEVE THE PIECE WITH NO ADVERSE PATIENT CONSEQUENCES. INVESTIGATION OF THIS EVENT IS IN PROGRESS AND ADDITIONAL INFORMATION WILL BE PROVIDED AS IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE MORECELLEX TISSUE MORCELLATOR LAPAROSCOPE, GYNECOLOGIC HET ETHICON, INC. NA MT213864

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK