BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URETERO-RENO FIBERSCOPE

    MDR report key: 15822833 · Received November 18, 2022

    Report

    Report Number
    9610595-2022-04201
    Event Type
    Malfunction
    Date Received
    November 18, 2022
    Date of Event
    September 9, 2021
    Report Date
    January 10, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FGB
    UDI-DI
    04953170403811
    PMA / PMN Number
    K181451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVALUATION AND SERVICE. ACCORDING TO THE QUALITY INSPECTION RESULTS, THE DEVICE PASSED THE LEAK TEST. THERE WAS A DEEP DENT AND CORROSION NEAR THE METAL RING AT THE DISTAL END PLASTIC COVER. THERE WAS A CORROSION OBSERVED INSIDE THE CHANNEL MOUTH PIECE AT THE CONTROL BODY. THE CUSTOMER HAS BEEN CONTACTED TO OBTAIN MORE DETAILED INFORMATION REGARDING THE REPORTED EVENT, BUT NO ADDITIONAL INFORMATION WAS PROVIDED AS OF YET. THIS REPORT WILL BE SUPPLEMENTED WHEN NEW INFORMATION BECOMES AVAILABLE. INVESTIGATION ACTIVITIES HAVE BEEN OPENED TO MANAGE THE ACTIONS RELATED TO THIS REPORT AND ANY REQUIRED MDR REPORTING EVENT1: INSTRUMENT CHANNEL BLOCKAGES/RESTRICTIONS WITH FOREIGN MATERIAL, IT CANNOT BE REMOVED WHILE CLEANING. (IT WAS NOT POSSIBLE TO IDENTIFY WHEN THE FOREIGN MATERIAL HAS BEEN ATTACHED TO THE ENDOSCOPE. THERE IS A POSSIBILITY THAT THE SUBJECT DEVICE WAS USED TO THE PATIENT WITH THE FOREIGN MATERIAL ATTACHED.) PAE JUDGEMENT: PAE INVESTIGATION REQUIRED: NECESSARY TIER CLASSIFICATION: TIER2 UNIVERSAL FAILURE CODE: SSN0001Y CONTAINMENT: NOT REQUIRED BECAUSE THERE IS NO FACT OR POSSIBILITY INDICATING THAT THE REPORTED EVENT MIGHT SPREAD ANY FURTHER. EVENT2: D/E PLASTIC C-BODY: CORROSION NEAR THE METAL RING CONTROL BODY: CHANNEL MOUTH PEICE CORROSION INSIDE(IT WAS NOT POSSIBLE TO IDENTIFY WHEN THE FOREIGN MATERIAL HAS BEEN ATTACHED TO THE ENDOSCOPE. THERE IS A POSSIBILITY THAT THE SUBJECT DEVICE WAS USED TO THE PATIENT WITH THE FOREIGN MATERIAL ATTACHED.) PAE JUDGEMENT: PAE INVESTIGATION REQUIRED: NECESSARY TIER CLASSIFICATION: TIER2 UNIVERSAL FAILURE CODE: SSN0001Y. CONTAINMENT: NOT REQUIRED BECAUSE THERE IS NO FACT OR POSSIBILITY INDICATING THAT THE REPORTED EVENT MIGHT SPREAD ANY FURTHER. OTHER EVENTS WERE APPLICABLE TO TIER3, INVESTIGATION UNNECESSARY (AS FOLLOWS). -D/E PLASTIC C-BODY DEEP DENT: SSE2506A.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND CORRECTION TO H3. PLEASE SEE UPDATES TO D8, D9, H3, H4, H6 AND H10. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE OF THE FOREIGN MATERIAL/BIOBURDEN, AS WELL AS THE CORROSION NEAR THE METAL RING AND CORROSION IN THE CHANNEL MOUTHPIECE WERE UNABLE TO BE IDENTIFIED. THE EVENT CAN BE DETECTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: ¿INSPECTION OF THE ENDOSCOPE : INSPECT THE EXTERNAL SURFACE OF THE ENTIRE INSERTION SECTION, INCLUDING THE BENDING SECTION AND THE DISTAL END FOR DENTS, BULGES, SWELLING, SCRATCHES, PEELING OF COATING, 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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT DURING REPROCESSING A BIOBURDEN WAS FOUND AND IT CANNOT BE REMOVED WHILE CLEANING. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238586 URETERO-RENO FIBERSCOPE URETERO-RENO FIBERSCOPE FGB AIZU OLYMPUS CO., LTD. URF-P7 04953170403811

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown