BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 300376 · Received October 12, 2000

    Report

    Report Number
    9610773-2000-00036
    Event Type
    Malfunction
    Date Received
    October 12, 2000
    Report Date
    September 13, 2000
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FEJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN OLYMPUS SALES REP REPORTED INTERMITTENT LOSS OF IMAGE DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE SAME VIDEO LAPAROSCOPE AND THERE NO INJURIES RELATED TO THE OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS VIDEO LAPAROSCOPE FEJ OLYMPUS WINTER & IBE GMBH A4801A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN