BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE MORCELLEX TISSUE MORCELLATOR

    MDR report key: 3241557 · Received July 22, 2013

    Report

    Report Number
    2210968-2013-14029
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    July 2, 2013
    Report Date
    July 8, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    HET
    PMA / PMN Number
    K100280
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY AND FUNCTIONALLY EVALUATED. UPON EVALUATION, THE BLADE FAILED TO ROTATE; IT IS LIKELY THAT THE ACCUMULATION OF TISSUE DURING THE PROCEDURE PREVENTED THE BLADE FROM CONTINUING TO ROTATE AS INTENDED. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC HYSTERECTOMY ON (B)(6) 2013. DURING THE PROCEDURE, THE DEVICE WOULD STOP AND GO. THE PROCEDURE WAS COMPLETED BY REMOVING THE TISSUE FROM THE VAGINA. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341770 GYNECARE MORCELLEX TISSUE MORCELLATOR LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) HET ETHICON INC. UNK MT217455

    Patients

    Seq Age Sex Outcome Treatment
    1