BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE MORCELLEX* TISSUE MORCELLATOR

    MDR report key: 2833089 · Received November 15, 2012

    Report

    Report Number
    2210968-2012-07294
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 22, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    HET
    PMA / PMN Number
    K100280
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2012-07295. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4): THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY AND FUNCTIONALLY EVALUATED. THE DEVICE OPERATED AS INTENDED DURING EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC MYOMECTOMY ON (B)(6) 2012. DURING THE PROCEDURE, WHEN THE SURGEON ACTIVATED THE FOOTSWITCH, THE CABLE OF THE DEVICE TWISTED AROUND ITSELF AND THE SURGEON HEARD A STRANGE NOISE. WHEN SURGEON CHANGED THE ROTATION, THE SITUATION DIDN'T CHANGE. ANOTHER LIKE DEVICE WAS USED. THERE WERE 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 NI

    Patients

    Seq Age Sex Outcome Treatment
    1