BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE X-TRACT MORCELLATOR

    MDR report key: 2113383 · Received June 3, 2011

    Report

    Report Number
    2210968-2011-00700
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 10, 2011
    Manufacturer
    ETHICON
    Product Code
    HET
    PMA / PMN Number
    K993801
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    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 PERFORMED ACCORDING TO SPECIFICATION.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: (B)(4) 2011. THE PROCEDURE WAS A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. THE NURSE THAT WAS IN THE CASE WITH THE SURGEON THOUGHT THAT THE CAUSE OF THE PROBLEM WAS THE SIZE OF THE PATIENT'S UTERUS AND THAT THE SURGEON WAS GRASPING TOO MUCH TISSUE.

    Additional Manufacturer Narrative · 1

    (B)(4). INSUFFICIENT DRIVE OF DISPOSABLE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2011. DURING THE PROCEDURE, THE DEVICE WAS NOT WORKING AS WELLL AS IT SHOULD HAVE. IT IS UNKNOWN HOW OR IF THE CASE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE 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 47 YR