BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE X-TRACT MORCELLATOR

    MDR report key: 1962926 · Received December 22, 2010

    Report

    Report Number
    2210968-2010-01727
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2010
    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): INSUFFICIENT DRIVE OF DISPOSABLE. CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVAL IS NOT YET COMPLETE. ANY FURTHER INFO DERIVED FROM THE EVAL WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. IN ADDITION, A REVIEW OF THE DEVICE MFG RECORDS WAS CONDUCTED AND THE DEVICE MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY PROCEDURE ON (B)(6) 2010. WHEN THE MOTOR DRIVE UNIT WAS ACTIVATED, IT MADE A LOUD BUZZING NOISE. SHORTLY THEREAFTER, THE MOTOR DRIVE UNIT SHUT DOWN COMPLETELY. THE SURGEON SWITCHED THE HANDPIECE, AND THE SAME NOISE CONTINUED TO OCCUR. THE SURGEON WAS ABLE TO GET THE MOTOR DRIVE UNIT TO OPERATE FOR 5-10 SECONDS AT A TIME TO CONTINUE THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SCISSORS TO CUT THE REMAINDER OF THE UTERUS INTO SMALL PIECES. INCISIONS WERE NOT MADE LARGER AND THE PROCEDURE WAS NOT CONVERTED TO AN OPEN PROCEDURE. THERE ARE NO KNOWN ADVERSE EFFECTS TO THE PT.

    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 UNK