BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE MORCELLEX* TISSUE MORCELLATOR

    MDR report key: 3021928 · Received March 26, 2013

    Report

    Report Number
    2210968-2013-02953
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 7, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    HET
    PMA / PMN Number
    K100280
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-02954. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH. THIS MEDWATCH REPORT IS IN RESPONSE TO RECEIPT OF FACILITY REPORT #3100500000-2013-8006.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT AND AN UNUSED DEVICE FROM THE SAME BATCH NUMBER WERE RETURNED FOR EVALUATION. THE DEVICES WAS VISUALLY AND FUNCTIONALLY EVALUATED. UPON EVALUATION FOR BOTH DEVICES, THE DRIVE CABLE STOPPED ROTATION WHEN THE TRIGGER WAS RELEASED. THE DEVICES OPERATED AS INTENDED DURING EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 ROBOTIC LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY ON (B)(6) 2013. DURING THE PROCEDURE, THE DEVICE WOULD ACTIVATE CONTINUOUSLY WHEN THE TRIGGER WAS ACTIVATED. THE BLADE WOULD KEEP TURNING WHEN THE TRIGGER WAS RELEASED. ANOTHER LIKE DEVICE WAS USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123282 GYNECARE MORCELLEX* TISSUE MORCELLATOR LAPAROSCOPE, GYNECOLOGIC HET ETHICON, INC. NA MT217609

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR