BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE MORCELLEX* TISSUE MORCELLATOR

    MDR report key: 3143736 · Received June 3, 2013

    Report

    Report Number
    2210968-2013-06437
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    December 14, 2012
    Report Date
    May 6, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    HET
    PMA / PMN Number
    K100280
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INFORMATION CONTAINED IN THIS FILE HAS BEEN DETERMINED TO BE A DUPLICATE OF THE EVENT REPORTED IN MEDWATCH 2210968-2013-10007. THEREFORE, THIS MEDWATCH 2210968-2013-06437 WILL BE VOIDED. ALL INFORMATION REGARDING THIS EVENT WILL RESIDE IN MEDWATCH 2210968-2013-10007.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY AND FUNCTIONALLY EVALUATED. THE DEVICE WAS RECEIVED IN A CONDITION WHICH DOES NOT MEET SPECIFICATION. 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. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-00753. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY ON (B)(6) 2012. DURING THE PROCEDURE THE DEVICE SEIZED UP DURING MORCELLATING. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245612 GYNECARE MORCELLEX* TISSUE MORCELLATOR LAPAROSCOPE, GYNECOLOGIC HET ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1