BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE X-TRACT MORCELLATOR

    MDR report key: 3082914 · Received April 29, 2013

    Report

    Report Number
    2210968-2013-04647
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    HET
    PMA / PMN Number
    K993801
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 DRIVE COUPLER REQUIRED REPLACEMENT.

    Additional Manufacturer Narrative · 1

    (B)(4) - DAMAGE TO DRIVE CONNECTOR OR COUPLING. 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 ON (B)(6) 2013, DURING A ROUTINE HOSPITAL INSPECTION, THE DISPOSABLE WOULDN'T ROTATE WHEN ATTACHED TO THE DEVICE DURING TESTING. THERE WAS A RATTLING NOISE FROM INSIDE THE UNIT AND IT WAS DISCOVERED THAT THE DRIVE COUPLER WAS DAMAGED WHEN THE CASE WAS OPENED. THE EVENT DID NOT OCCUR DURING A PROCEDURE AND THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185763 GYNECARE X-TRACT MORCELLATOR MOTOR DRIVE UNIT HET ETHICON, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1