BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA DUODENOVIDEOSCOPE

    MDR report key: 12961704 · Received December 8, 2021

    Report

    Report Number
    8010047-2021-15755
    Event Type
    Malfunction
    Date Received
    December 8, 2021
    Report Date
    March 2, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    PMA / PMN Number
    K954451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    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. IT HAS BEEN OVER 19 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. 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, CONTAMINATION UNDER THE LG LENS WAS VERIFIED. SEVERAL TRACES OF DISCOLORATION FOUND. THE FOLLOWING CAUSES WERE SURMISED: 1.) LG LENS GLUE GOT CHIPPED BY STRESS ON THE DISTAL END OR CHEMICAL STRESS. DIRT ENTERED FROM THE DISTAL END. 2.) MOISTURE INVADED ON THE DEVICE FROM THE LEAKING POINT, WHICH CORRODED COMPONENTS INSIDE THE LG LENS. CORROSION PRODUCT WAS LEFT AS DIRT. THE REPORTED FINDING IS LIKELY A RESULT OF INCORRECT REPROCESSING OF THE DEVICE. MAJOR REPAIR IS REQUIRED TO RETURN THE DEVICE TO OEM STANDARDS. OTHER FINDINGS DETECTED WERE AS FOLLOWS: DUE TO DEFORMATION OF S-COVER, WATER TIGHTNESS IS LOST; AW-CYLINDER HAS DISCOLORATION; S-CYLINDER HAS DISCOLORATION; FORCEPS CHANNEL PORT IS DEFORMED; SW1 HAS A CUT; S-CONNECTOR HAS DISCOLORATION; LG-COVER GLASS HAS A SCRATCH; EL-CONNECTOR HAS DISCOLORATION; DUE TO DAMAGE ON CONNECTING TUBE, INSULATION RESISTANCE VALUE DOES NOT MEET THE STANDARD VALUE; DUE TO A SCRATCH ON C-COVER, INSULATION RESISTANCE VALUE AT DISTAL END DOES NOT MEET THE STANDARD VALUE; UNIVERSAL CORD HAS A SCRATCH. THE INSTRUCTION MANUAL IDENTIFIES THE FOLLOWING RELATED VERBIAGE: ¿DO NOT STRIKE, HIT, OR DROP THE ENDOSCOPE¿S DISTAL END, INSERTION TUBE, BENDING SECTION, CONTROL SECTION, UNIVERSAL CORD, OR ENDOSCOPE CONNECTOR. ALSO, DO NOT BEND, PULL, OR TWIST 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, BURNS, BLEEDING, AND/OR PERFORATIONS. IT COULD ALSO CAUSE PARTS OF THE ENDOSCOPE TO FALL OFF INSIDE THE PATIENT. INSPECT THE EXTERNAL SURFACE OF THE ENTIRE INSERTION SECTION INCLUDING THE BENDING SECTION AND THE DISTAL END FOR DENTS, BULGES, SWELLING, SCRATCHES, HOLES, SAGGING, TRANSFORMATION, BENDS, ADHESION OF FOREIGN BODIES, MISSING PARTS, PROTRUDING OBJECTS, OR OTHER IRREGULARITIES.¿ OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED, AND AN INITIAL EVALUATION WAS CONDUCTED BY OLYMPUS; HOWEVER, INVESTIGATION IS ONGOING. DURING THE INITIAL EVALUATION, THE USER REPORT WAS CONFIRMED, A LEAK WAS NOTED AT THE S-COVER UNIT PACKING AREA DUE TO ADHESIVE FAILURE. THIS LEAKAGE LEAD TO THE UNIT FAILING THE DISTAL END INSULATION TESTS. ADDITIONALLY, IT WAS DISCOVERED THAT THE LIGHT GUIDE COVER LENS HAD BEEN CONTAMINATED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE FOLLOWING THE DEVICE EVALUATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    THE CUSTOMER ORIGINALLY RETURNED THEIR EVIS EXERA DUODENOVIDEOSCOPE DUE TO AN AIR/WATER LEAKAGE. ADDITIONAL DETAILS RELATING TO THE PATIENT AND THE EVENT HAVE BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME. THERE WAS NO PATIENT HARM OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT. DURING THE DEVICE EVALUATION, IT WAS DISCOVERED THAT THE ADHESIVE ON THE DISTAL END OF THE UNIT WAS GAPPED AND PEELING. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE PEELING ADHESIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1859870 EVIS EXERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-145

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown