BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA LLL COLONOVIDEOSCOPE

    MDR report key: 12715804 · Received October 28, 2021

    Report

    Report Number
    8010047-2021-13776
    Event Type
    Malfunction
    Date Received
    October 28, 2021
    Report Date
    March 1, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    UDI-DI
    04953170305153
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS EVALUATED BY OLYMPUS. IT WAS NOTED THAT THE PASSIVE BENDING SECTION WAS SEPARATED FROM THE ACTIVE BENDING SECTION DUE TO ROTATION AT A TORQUE EXCEEDING THE SPECIFIED VALUE. THE INVESTIGATION IS ONGOING AND THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS SUBMITTED TO CORRECT SECTION DATE RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND TO CORRECT INFORMATION PROVIDED ON THE INITIAL REPORT. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE LEGAL MANUFACTURER'S INVESTIGATION, DETACHED PASSIVE BENDING TUBE AND MISSING SCREW WERE CONFIRMED. THIS ITEM IS CAUSED BY ROTATION AT A TORQUE EXCEEDING THE SPECIFIED VALUE (PASSIVE BENDING SECTION SEPARATED FROM ACTIVE BENDING SECTION (THERE IS THE EDGE LEADING TO PERFORATION). IT WAS SURMISED THAT THE EVENT OCCURRED BECAUSE PHYSICAL STRESS SUCH AS VIBRATION OR IMPACT WAS APPLIED AROUND PASSIVE BENDING SECTION. THE INSTRUCTION MANUAL IDENTIFIES THE FOLLOWING RELATED VERBIAGE WHICH MAY HELP PREVENT THE PHENOMENON: "PREPARATION AND INSPECTION: INSPECTION OF THE ENDOSCOPE: HOLDING THE CONTROL SECTION WITH ONE HAND, CAREFULLY RUN YOUR OTHER HAND BACK AND FORTH OVER THE ENTIRE LENGTH OF THE INSERTION SECTION. CONFIRM THAT NO OBJECTS OR METALLIC WIRE PROTRUDE FROM THE INSERTION SECTION. ALSO, CONFIRM THAT THE INSERTION TUBE IS NOT ABNORMALLY RIGID. USING BOTH HANDS, BEND THE INSERTION TUBE OF THE ENDOSCOPE INTO A SEMICIRCLE. THEN, MOVING YOUR HANDS AS SHOWN BY THE ARROWS IN FIGURE 3.4, CONFIRM THAT THE ENTIRE INSERTION TUBE CAN BE SMOOTHLY BENT TO FORM A SEMICIRCLE AND THAT THE INSERTION TUBE IS PLIABLE. WHEN INSPECTING ENDOSCOPES WITH FLEXIBILITY ADJUSTMENT, PERFORM THE TEST WITH THE INSERTION TUBE AT BOTH ITS MOST FLEXIBLE AND MOST RIGID SETTINGS." USERS CAN REDUCE/PREVENT THE SUGGESTED EVENT BY HANDLING THE DEVICE IN ACCORDANCE WITH THE FOLLOWING IFU: "IMPORTANT INFORMATION ¿ PLEASE READ BEFORE USE. WARNING: DO NOT STRIKE, BEND, HIT, PULL, TWIST, OR DROP THE ENDOSCOPE¿S DISTAL END, INSERTION TUBE, BENDING SECTION, CONTROL SECTION, UNIVERSAL CORD, OR ENDOSCOPE CONNECTOR WITH EXCESSIVE FORCE. THE ENDOSCOPE MAY BE DAMAGED AND COULD CAUSE PATIENT INJURY, SUCH AS BURNS, BLEEDING, AND/OR PERFORATION. IT COULD ALSO CAUSE PARTS OF THE ENDOSCOPE TO FALL OFF INSIDE THE PATIENT." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    A USER FACILITY RETURNED THE OLYMPUS, MODEL CF-H190L, EVIS EXERA III COLONOVIDEOSCOPE TO OLYMPUS FOR REPAIR DUE TO A REPORT OF "BOWDEN CABLE NOT IN ORDER; ANGULATION PROBLEMS." UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, IT WAS NOTED THAT THE PASSIVE BENDING SECTION WAS SEPARATED FROM THE ACTIVE BENDING SECTION. THIS REPORT IS SUBMITTED DUE TO THE MALFUNCTION OF PASSIVE BENDING SECTION SEPARATED FROM THE ACTIVE BENDING SECTION. THERE WAS NO PATIENT INJURY, ASSOCIATED WITH THE PROBLEM, REPORTED TO OLYMPUS.

    Description of Event or Problem · 0

    ADDITIONALLY, AFTER CONSULTATION WITH THE USERS, IT WAS REPORTED THAT THE ENDOSCOPE WAS IN STORAGE FOR A LONG TIME AND THE FAULT WAS DETECTED DURING A VISUAL AND FUNCTIONAL CHECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1614122 EVIS EXERA LLL COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. CF-H190L 04953170305153

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown