BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URETERO-RENO FIBERSCOPE

    MDR report key: 12055793 · Received June 24, 2021

    Report

    Report Number
    8010047-2021-07914
    Event Type
    Malfunction
    Date Received
    June 24, 2021
    Report Date
    August 18, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FGB
    PMA / PMN Number
    K172298
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP.(OMSC) BUT WAS RETURNED TO OLYMPUS REPAIR CENTER IN (B)(6) FOR EVALUATION. OLYMPUS REPAIR CENTER INSPECTED THE DEVICE AND CONFIRMED THE FOLLOWING: DAMAGE TO THE DISTAL END CAP AND BROKEN IMAGE GUIDE FIBER WERE FOUND. THE REPORTED EVENT MAY HAVE BEEN CAUSED BY MISHANDLING 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.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE DEVICE WAS EVALUATED AT OLYMPUS REPAIR CENTER IN (B)(4). AS A RESULT OF THE EVALUATION, THE FOLLOWING WAS CONFIRMED. THERE WAS A LEAKAGE FROM THE DISTAL END. THERE WAS AN INSULATION FAILURE IN THE INSERTION SECTION DUE TO THE CUTTING OF THE BENDING TUBE. AT THE USER FACILITY, THE SAME CASE AS THE REPORTED EVENT HAS OCCURRED IN THE PAST WITH THE SAME PRODUCT. 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. THE INSTRUCTION MANUAL PROVIDES THE IMPLEMENTATION OF A LEAKAGE TEST AFTER CLEANING THE ENDOSCOPE AND THE IMPLEMENTATION OF AN INSPECTION OF THE EXTERNAL SURFACE OF THE ENTIRE INSERTION SECTION. THE USER CAN PROPERLY DETECT THE REPORTED EVENT BY HANDLING THE DEVICE ACCORDING TO THE INSTRUCTION MANUAL. IN ADDITION, THE INSTRUCTION MANUAL PROVIDES WARNINGS ABOUT OPERATING THE ANGULATION CONTROL LEVER WITH EXCESSIVE FORCE AND INSERTING THE INSERTION TUBE WITH EXCESSIVE FORCE. THE USER CAN REDUCE / PREVENT THE OCCURRENCE OF THE REPORTED EVENT BY HANDLING THE DEVICE ACCORDING TO THE INSTRUCTION MANUAL. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED, BECAUSE THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP.(OMSC). HOWEVER, BASED ON THE FOLLOWING INFORMATION, THE BENDING TUBE MAY HAVE BEEN DAMAGED BY THE USER OPERATING THE BENDING SECTION WITH EXCESSIVE FORCE. ACCORDING TO THE DEVICE INSPECTION RESULT, A PART OF THE BENDING TUBE WAS STICKING OUT FROM THE CUT IN THE BENDING SECTION RUBBER. ACCORDING TO THE INSTRUCTION MANUAL, PUSHING THE INSERTION SECTION WITH EXCESSIVE FORCE CAN DAMAGE THE BENDING SECTION. IN THE PAST SIMILAR CASES, THE USER OPERATED THE BENDING SECTION WITH EXCESSIVE FORCE, CAUSING THE BENDING TUBE TO BREAK AND STICK OUT OF THE BENDING SECTION RUBBER. ACCORDING TO CAPA (B)(4), THE BENDING TUBE IS BROKEN BY THE USER INSERTING THE DEVICE INTO THE LOWER KIDNEY CALYX OR URETER WITH EXCESSIVE FORCE WHILE THE BENDING SECTION IS BENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    THE USER FACILITY FOUND THAT THE INSERTION TUBE WAS DAMAGED BEFORE USE AND RETURNED THE DEVICE TO THE OLYMPUS REPAIR CENTER IN (B)(6). THEN, OLYMPUS REPAIR CENTER INSPECTED THE DEVICE AND FOUND THAT THE METAL BRAID OF THE BENDING TUBE WAS STICKING OUT, WHICH BROKE THE ADHESIVE OF THE BENDING SECTION RUBBER. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957519 URETERO-RENO FIBERSCOPE URETERO-RENO FIBERSCOPE FGB OLYMPUS MEDICAL SYSTEMS CORP. URF-P6

    Patients

    Seq Age Sex Outcome Treatment
    1