BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE X-TRACT MORCELLATOR

    MDR report key: 2113245 · Received June 3, 2011

    Report

    Report Number
    2210968-2011-00714
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 13, 2011
    Manufacturer
    ETHICON
    Product Code
    HET
    PMA / PMN Number
    K993801
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    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. IN ADDITION, A REVIEW OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED AND THE DEVICE 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 AND FUNCTIONALLY EVALUATED. THE REPORTED SYMPTOM COULD NOT BE DUPLICATED. THE DEVICE MET PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY ON (B)(6) 2011. DURING THE PROCEDURE, THE DISPOSABLE STOPPED WORKING AND THE LEDS STARTED BLINKING. THE SURGEON ALLOWED THE MOTOR TO COOL DOWN, BUT THE PROBLEM STILL PERSISTED AFTER 30 MINUTES. A SECOND DISPOSABLE WAS TRIED, BUT THE MOTOR DRIVE UNIT STILL WOULD NOT WORK, SO THE REMAINING UTERUS WAS CUT INSIDE OF AN ENDO BAG AND REMOVED LAPAROSCOPICALLY. THERE WAS NO EXTENSION OF INCISIONS AND NO UNPLANNED DISSECTION. THE PATIENT'S CERVIX REMAINED INTACT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE X-TRACT MORCELLATOR LAPAROSCOPIC MORCELLATOR HET ETHICON NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1