BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE X-TRACT MORCELLATOR

    MDR report key: 1060536 · Received June 12, 2008

    Report

    Report Number
    2210968-2008-00414
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 1, 2007
    Report Date
    May 13, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    HET
    PMA / PMN Number
    K993801
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 06/12/2008. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SOMETIME DURING 2007, DURING UNIT TESTING PRIOR TO PATIENT USE, WHEN THE HANDPIECE WAS POINTED DOWN AT A FORTY-FIVE DEGREE ANGLE, THE LIGHTS WOULD FLICKER AND UNIT WOULD SUPPLY INTERMITTENT POWER TO THE HANDPIECE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE PATIENT CONSEQUENCES OCCURRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA