BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON - J & J

    MDR report key: 1039104 · Received May 6, 2008

    Report

    Report Number
    MW5006713
    Event Type
    Injury
    Date Received
    May 6, 2008
    Date of Event
    April 9, 2008
    Report Date
    April 24, 2008
    Manufacturer
    ETHICON WOMENS HEALTH & UROLOGY, DIV OF ETHICON INC JOHNSON & JOHNSON
    Product Code
    HET
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PROBLEMS WITH MORCELLATOR DURING PART OF SURGERY. USED 2 SEPARATE HANDPIECES. ABLE TO FINISH THE CASE BUT SUGGESTED BY SURGEON, THAT MORCELLATOR MOTOR DRIVE NOT STRONG ENOUGH. PERIODIC PROBLEMS IN THESE TYPES OF CASES. MACHINE WAS SENT OUT FOR CALIBRATION IN 02/2008. NO ADVERSE EFFECT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON - J & J MORCELLATOR HET ETHICON WOMENS HEALTH & UROLOGY, DIV OF ETHICON INC JOHNSON & JOHNSON 00186-00020-S UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization