BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE X-TRACT MORCELLATOR

    MDR report key: 1872186 · Received October 12, 2010

    Report

    Report Number
    2210968-2010-01292
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    September 6, 2010
    Report Date
    September 13, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    HET
    PMA / PMN Number
    K993801
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BROKEN PNEUMATIC SWITCH. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INSERVICE DEMONSTRATION ON (B)(6) 2010 THE PLASTIC TIP BROKE OFF THE BACK OF THE MOTOR DRIVE UNIT. THE MOTOR WOULD NOT RUN AS WELL. THERE WAS NO CASE OR 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