BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE X-TRACT MORCELLATOR

    MDR report key: 2163119 · Received July 15, 2011

    Report

    Report Number
    2210968-2011-00899
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    ETHICON
    Product Code
    HET
    PMA / PMN Number
    K993801
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 REPORTED SYMPTOM OF THE DEVICE NOT ACTIVATING THE DISPOSABLE WAS DUPLICATED. THE CAUSE WAS DUE TO A LOOSE SET SCREW ON THE CPC COUPLER. (B)(4) - DAMAGE TO DRIVE CONNECTOR OR COUPLING.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY ON (B)(6) 2011. DURING THE PROCEDURE, THE MOTOR DRIVE UNIT SPUN THE DEVICE BLADES INTERMITTENTLY AND WAS PULSATING. THIS OCCURRED WITH TWO HANDPIECES. THE PROCEDURE WAS COMPLETED USING A POUCH WITH NO ADVERSE PATIENT CONSEQUENCES.

    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