BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAAB OP SCOPE STR FWD 0

    MDR report key: 271675 · Received April 3, 2000

    Report

    Report Number
    1219655-2000-00049
    Event Type
    Injury
    Date Received
    April 3, 2000
    Date of Event
    February 9, 2000
    Report Date
    April 3, 2000
    Manufacturer
    JOHNSON & JOHNSON PROFESSIONAL, INC.
    Product Code
    GWG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO INTERNATIONAL AFFILIATE; DOCTOR SAID THAT DR FAILED IN THE OPERATION BECAUSE THE TELESCOPE WAS CLOUDY AND DR COULD NOT SEE VERY WELL. IT WAS REPORTED THAT SOME DIFFICULTIES IN SPEECH AND DEFECTS IN MEMORY WERE SEEN IN THE PT AFTER THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAAB OP SCOPE STR FWD 0 ENDOSCOPE, NEUROLOGICAL GWG JOHNSON & JOHNSON PROFESSIONAL, INC. NA LM01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention