BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED ENDOSCOPE

    MDR report key: 120173 · Received September 15, 1997

    Report

    Report Number
    1030489-1997-00137
    Event Type
    Injury
    Date Received
    September 15, 1997
    Date of Event
    July 23, 1997
    Report Date
    July 23, 1997
    Manufacturer
    SOFAMOR DANEK MEDICAL, INC.
    Product Code
    KOG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY LENS ON ENDOSCOPE BECAME CRACKED. SURGEON HAD TO CONVERT TO AN OPEN PROCEDURE BECAUSE OF A COMBINATION OF EQUIPMENT AND ANATOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MED ENDOSCOPE ENDOSCOPE KOG SOFAMOR DANEK MEDICAL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other