BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE MORCELLEX* TISSUE MORCELLATOR

    MDR report key: 2834611 · Received November 15, 2012

    Report

    Report Number
    2210968-2012-07323
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    July 25, 2012
    Report Date
    October 26, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    HET
    PMA / PMN Number
    K100280
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BLADE WILL NOT ADVANCE. 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. 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 ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY EVALUATED. DURING EVALUATION, THE MAIN HOUSING WAS DROPPED ON THE FLOOR AND IT CRACKED OPEN DUE TO IMPACT. DURING THE INTERIOR EVALUATION, TISSUE WAS OBSERVED IN DUCK BILL HOUSING. THERE WAS NO TRACE OF TISSUE BETWEEN THE DUCKBILL HOUSING AND THE INNER AND OUTER DRIVE TUBES. BASED ON THIS EVIDENCE, THE BLADE MOST LIKELY ADVANCED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2012. DURING THE PROCEDURE, THE BLADED WOULD NOT EXTEND. AFTER TWENTY TRIES, THEY WERE ABLE TO MORCELLATE THE TISSUE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE MORCELLEX* TISSUE MORCELLATOR LAPAROSCOPE, GYNECOLOGIC HET ETHICON, INC. NA MT216614

    Patients

    Seq Age Sex Outcome Treatment
    1