BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUJINON

    MDR report key: 71165 · Received February 20, 1997

    Report

    Report Number
    71165
    Event Type
    Injury
    Date Received
    February 20, 1997
    Date of Event
    August 2, 1996
    Report Date
    February 20, 1997
    Manufacturer
    FUJINON, INC.
    Product Code
    FET
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PURCHASE DATE 5/31/96. ON 8/2/96, REPAIR COLONOSCOPE. ON 8/28/96, REPAIR EYE PROCESSOR. SWITCH FOR PUMP FELL APART AND ON TO FLOOR. EGD SCOPE CHANNEL PROBLEMS. ON 10/3/96, COLONOSCOPE (2 EACH), COLOR, GLARE AND PICTURE CLARITY PROBLEMS MADE BOTH UNSAFE FOR PT USE. ON 10/9/96, CO SENT ONE SCOPE TO REPLACE THE TWO SCOPES SENT FOR REPAIR, THUS LIMITING THE SPEED AND NUMBER OF CASES CENTER WAS ABLE TO PERFORM IN ONE DAYS OPERATION. ON 10/23/96, LOANER SCOPE FROM CO INOPERATIVE. DR CANCELLED ALL CASES SCHEDULED AFTER 10/23/96 UNLESS PROBLEM RESOLVED. CO SENT THE SALESPERSON (NOT THE REPAIR TECH). IT WAS THE SALESPERSON'S DETERMINATION THAT THE PROCESSOR WAS AGAIN INOPERATIVE. SCOPES SENT BACK ON 10/3/96 WERE DEEMED OK AND THE PROCESSOR WAS FOUND AT FAULT. DURING THE MONTHS OF DECEMBER AND JANUARY, CENTER CONTINUED TO HAVE PROBLEMS WITH PRINTER, COLOR, LIGHT. IT WAS AGAIN DETERMINED THAT THE PROCESSOR WAS INOPERATIVE. REGIONAL MANAGER FOR CO OPTED TO REPLACE ENTIRE SYSTEM ONCE AGAIN NO LATER THAN FRIDAY, 2/21/97. OTHER MINOR PROBLEMS NOT YET FIXED. (1) CONTROL BUTTONS ALWAYS POPPING OFF DURING PROCEDURES. (2) CLEANING KITS FOR SCOPES WERE ALWAYS DEFECTIVE. CENTER HAD TO ORDER SPECIAL PARTS FROM ANOTHER CO AND USE PARTS FROM A THIRD CO'S CLEANERS TO PROPERLY MAINTAIN SCOPES. ON THREE OCCASIONS, SCOPES AND/OR PROCESSOR BECAME DEFECTIVE BEFORE R DURING PROCEDURE CAUSING THE FOLLOWING UNSAFE CONDITIONS: (1). PRE-OP ALREADY ACCOMPLISHED, PT WAS RESCHEDULED AND PUT AT RISK. (2). LIGHT GOING OUT DURING USE CAUSING PROBLEMS WITH A "BLIND EXIT". (3). ON SEVERAL OCCASIONS THE OLD SCOPES WERE PULLED FROM STORAGE TO ENABLE THE CONTINUATION OF A PROCEDURE. AT NO TIME HAS CO LEFT A PAPER TRAIL OF THEIR REASONS FOR EQUIPMENT FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUJINON VIDEO ENDOSCOPE FET FUJINON, INC. EXP-201 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Life Threatening