BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE X-TRACT MORCELLATOR

    MDR report key: 3040288 · Received April 8, 2013

    Report

    Report Number
    2210968-2013-03563
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Report Date
    March 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: DEVICE FAILURE WAS RELATED TO USER HANDLING. UPON EVALUATION, THE UNIT WAS DETERMINED TO HAVE BEEN DROPPED/DAMAGED BY THE USER. IT WAS FOUND THAT THE FLEX COUPLER WAS BENT, MISSING A RUBBER FOOT, AND ALL LID CLOSURE HARDWARE WAS MISSING. THE DAMAGE TO THE DEVICE WAS FOUND TO BE A RESULT OF USER MISHANDLING. 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 THE DEVICE WAS POSSIBLY DROPPED AND DAMAGED AND THERE WERE SOME SCREWS MISSING. NO OTHER INFORMATION AVAILABLE. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143605 GYNECARE X-TRACT MORCELLATOR LAPAROSCOPIC MORCELLATOR HET ETHICON, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1