BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE X-TRACT MORCELLATOR

    MDR report key: 2032818 · Received March 29, 2011

    Report

    Report Number
    2210968-2011-00348
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Report Date
    March 3, 2011
    Manufacturer
    HEI, INC.
    Product Code
    HET
    PMA / PMN Number
    K993801
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 03/29/2011. (B)(4) - INSUFFICIENT DRIVE OF DISPOSABLE. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. 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 AN UNKNOWN DATE. DURING THE PROCEDURE, THE MOTOR DRIVE UNIT WAS DRIVING THE DISPOSABLE HANDPIECE SLOWLY. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE WITH NO ADVERSE PATIENT CONSEQUENCES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1