BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE MORCELLEX* TISSUE MORCELLATOR

    MDR report key: 2925376 · Received January 22, 2013

    Report

    Report Number
    2210968-2013-00503
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Report Date
    January 2, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    HET
    PMA / PMN Number
    K100280
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). POOR BLADE PERFORMANCE. CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. 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): THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE BLADE FAILED TO ROTATE DURING THE EVALUATION. IT IS LIKELY THAT THE ACCUMULATION OF BLOOD, BODY FLUIDS, AND TISSUE PREVENTED THE DEVICE FROM CONTINUING TO OPERATE AS INTENDED. ALSO, THE RETURNED BLADE FAILED THE SHARPNESS TEST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN (B)(6) 2012. DURING THE PROCEDURE, THE BLADE OF THE DEVICE DID NOT WORK PROPERLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30641 GYNECARE MORCELLEX* TISSUE MORCELLATOR LAPAROSCOPE, GYNECOLOGIC HET ETHICON, INC. NA MT216441

    Patients

    Seq Age Sex Outcome Treatment
    1