BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GASTROSCOPE

    MDR report key: 7570 · Received January 4, 1994

    Report

    Report Number
    7570
    Event Type
    Malfunction
    Date Received
    January 4, 1994
    Date of Event
    April 26, 1993
    Report Date
    May 5, 1993
    Manufacturer
    OLYMPUS CORPORATION
    Product Code
    GCK
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    UPON COMPLETION OF E.R.C.P. PROCEDURE IT WAS NOTED THAT BLOCK DISTAL TIP OF SCOPE WAS MISSING. GASTROSCOPE WAS PASSED INTO PATIENT AND PLASTIC TIP WAS SNARED AND REMOVED PROMPTLY. COMPANY NOTIFIED RESPONDED AND REMOVED DAMAGED SCOPE AND DISTAL HOUSING. TO BE EXAMINED/INVESTIGATED AND REPORTED BACK TO NURSE MANAGER. LOANER SCOPE PROVIDED.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: MECHANICAL PROBLEM. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GASTROSCOPE GCK OLYMPUS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other