BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE MORCELLEX* TISSUE MORCELLATOR

    MDR report key: 2834563 · Received November 15, 2012

    Report

    Report Number
    2210968-2012-07353
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 19, 2012
    Report Date
    October 25, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    HET
    PMA / PMN Number
    K100280
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY AND FUNCTIONALLY EVALUATED. UPON EVALUATION, THE TRIGGER HOUSING WAS RECEIVED IN DISASSEMBLED CONDITION. WHEN THE RETURNED MAIN HOUSING WAS ATTACHED TO KNOWN GOOD TRIGGER, THE DEVICE DID NOT OPERATE AS INTENDED. THE BLADE FAILED TO ROTATE DURING THE EVALUATION.

    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. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOMECTOMY PROCEDURE ON (B)(6) 2012. AT FIRST, THE PRODUCT WORKED PROPERLY. AFTER THAT, THE BLADE STOPPED ROTATING DURING USE. ANOTHER LIKE DEVICE WAS USED WITH 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 MT217030

    Patients

    Seq Age Sex Outcome Treatment
    1