BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE X-TRACT MORCELLATOR

    MDR report key: 2103101 · Received May 25, 2011

    Report

    Report Number
    2210968-2011-00671
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    January 20, 2011
    Report Date
    May 2, 2011
    Manufacturer
    ETHICON
    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) - DAMAGE TO DRIVE CONNECTOR OR COUPLING. CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE REPORTED SYMPTOM WAS DUPLICATED. THE CAUSE WAS DUE TO A DAMAGED MOTOR COUPLER. 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 A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2011. DURING THE PROCEDURE, THE DEVICE WAS NOT WORKING SMOOTHLY AND MADE A LOUD GRINDING NOISE. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCE.

    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