BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE X-TRACT MORCELLATOR

    MDR report key: 1100303 · Received May 15, 2008

    Report

    Report Number
    1100303
    Event Type
    Malfunction
    Date Received
    May 15, 2008
    Date of Event
    April 9, 2008
    Report Date
    April 15, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    HET
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY IN 2008. DURING THE PROCEDURE, THE MOTOR DRIVE UNIT WAS NOT STRONG ENOUGH TO DRIVE THE HAND PIECES. THE DEVICE HAD VIBRATIONS AND TWO HAND PIECES WERE USED. THE SURGEON HAD TO PAUSE SEVERAL TIMES, SO THE DEVICE COULD COOL DOWN BEFORE PROCEEDING TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO ADVERSE PT CONSEQUENCES.

    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 UNKNOWN