BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II DUODENOVIDEOSCOPE

    MDR report key: 11221160 · Received January 24, 2021

    Report

    Report Number
    8010047-2021-01787
    Event Type
    Malfunction
    Date Received
    January 24, 2021
    Date of Event
    November 17, 2020
    Report Date
    March 18, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    UDI-DI
    04953170367311
    PMA / PMN Number
    K143153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. AN OLYMPUS FIELD SERVICE ENGINEER (FSE) INVESTIGATED THE PROCESS OF REPROCESSING FORCEPS ELEVATOR BY THE USER FACILITY AND CONFIRMED THE FOLLOWING; THE USER FACILITY OWNS OLYMPUS CHANNEL OPENING CLEANING BRUSH MH-507 AND SINGLE USE SOFT BRUSH MAJ-1888. AT THE USER FACILITY, BOTH BRUSHES ARE USED TO CLEAN THE FORCEPS ELEVATOR AND GLUTARALDEHYDE IS USED TO DISINFECT IT. THE USER FACILITY ALSO OWNS A J. MITRA & CO. PVT. LTD AUTOMATED ENDOSCOPE REPROCESSOR. THE FSE DISCUSSED WITH USERS ABOUT LEAKAGE AT THE BENDING SECTION AND FOUND THAT THE USER FACILITY HAD NOT REPROCESSED AND BRUSHED THE DEVICE PROPERLY, THE USER FACILITY HAD DONE ONLY PRE-CLEANING AT THE BEDSIDE. THEREFORE, IT WAS FOUND THAT THE INSUFFICIENT OR INCORRECT REPROCESSING VIDEO SCOPE HAD BEEN USED BY THE USER FACILITY. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) CONFIRMED THE FOLLOWING FROM THE INFORMATION PROVIDED BY OLYMPUS MEDICAL SYSTEMS INDIA PRIVATE LIMITED (OMSI); THERE IS POSSIBILITY THAT PHYSICAL STRESS WAS APPLIED TO THE DISTAL END, SINCE THE LIGHT GUIDE LENS WAS CHIPPED. THERE IS A POSSIBILITY THAT REPROCESSING BY THE USER WAS INAPPROPRIATE BECAUSE DIRT WAS ATTACHED TO THE CLEANABLE AREA OF THE ENTIRE DISTAL END. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED, BECAUSE THE DEVICE HAS NOT BEEN RETURNED TO OMSC. HOWEVER, BASED ON THE PAST SIMILAR CASES AND THE ABOVE INFORMATION, THE STAIN INSIDE THE LIGHT GUIDE LENS MAY HAVE BEEN CAUSED BY THE INGRESS OF WATER FROM THE MISSING PART OF THE LIGHT GUIDE LENS. OMSC DETERMINED THAT THE DAMAGE TO THE LIGHT GUIDE LENS WAS DUE TO PHYSICAL STRESS ON THE DISTAL END DUE TO INAPPROPRIATE HANDLING BY THE USER. FURTHERMORE, THE ADHESION OF FOREIGN MATERIAL AROUND THE FORCEPS ELEVATOR MAY HAVE BEEN CAUSED BY IMPROPER REPROCESSING BY THE USER THAT DID NOT REMOVE DIRT AROUND THE FORCEPS ELEVATOR. THE INSTRUCTION MANUAL PROVIDES PREVENTIVE MEASURES AGAINST THE REPORTED FAILURE MODE. DEVICE HISTORY RECORD (DHR) REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORPORATION BUT WAS RETURNED TO (B)(4) FOR EVALUATION. (B)(4) INSPECTED THE DEVICE AND CONFIRMED THE FOLLOWING; THE LIGHT GUIDE LENS WAS CHIPPED DUE TO A SHOCK CAUSED BY DROPPING AND KNOCKING THE DEVICE TO A HARD SURFACE OR OBJECT. THERE WAS A LEAKAGE AT THE BENDING SECTION RUBBER DUE TO BREAKAGE. FOREIGN MATERIAL ADHERING TO THE DISTAL END MAY HAVE BEEN CAUSED BY INSUFFICIENT CLEANING BY THE USER. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS INSPECTED THE DEVICE AT THE SERVICE DEPARTMENT OF OLYMPUS MEDICAL SYSTEMS (B)(4) PRIVATE LIMITED (B)(4) AND FOUND THAT THERE WAS A GAP OF ADHESIVE ON THE DISTAL END OF THE DEVICE, AND STAIN ENTERED THE INSIDE OF THE LIGHT GUIDE LENS THROUGH THE GAP. AND THE INSIDE OF THE LIGHT GUIDE LENS WAS DIRTY. IN ADDITION, FOREIGN MATERIAL WAS ATTACHED AROUND THE FORCEPS ELEVATOR AND UNDER THE FORCEPS ELEVATOR. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117696 EVIS EXERA II DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-Q180V 04953170367311

    Patients

    Seq Age Sex Outcome Treatment
    1