BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE DISTAL COVER

    MDR report key: 15319675 · Received August 30, 2022

    Report

    Report Number
    3003637092-2022-00028
    Event Type
    Malfunction
    Date Received
    August 30, 2022
    Date of Event
    August 3, 2022
    Report Date
    March 7, 2023
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT
    Product Code
    FDT
    UDI-DI
    04953170403019
    PMA / PMN Number
    K220587
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. 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 INVESTIGATION, ALTHOUGH THE ROOT CAUSE COULD NOT BE IDENTIFIED, THE LIKELY CAUSES FOR THE TIP COVER FALLING OFF ARE AS FOLLOWS: 1. CHEMICALS SUCH AS ANTI-FOG AGENTS ADHERED TO THE COVER AND WERE DAMAGED BY CHEMICAL ATTACK, MAKING IT EASY FOR THE COVER TO COME OFF THE SCOPE. 2. THE COVER WAS EASILY REMOVED FROM THE SCOPE DUE TO INSUFFICIENT ATTACHMENT TO THE SCOPE. 3. WHEN THE COVER WAS ATTACHED TO THE SCOPE, THE COVER WAS DAMAGED BY PUSHING IT DIAGONALLY, MAKING IT EASY FOR THE COVER TO COME OFF THE SCOPE. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU) WHICH STATE: ¿PLEASE MAKE SURE THAT THE DISTAL COVER IS INTACT WITHOUT ANY PROBLEM BEFORE INSTALLATION, AND IT HAS NO DAMAGE(CRACK) AFTER INSTALLATION.¿ ¿ALSO, DO NOT USE ANTI-FOG AGENTS AS IT IS KNOWN THAT ANTI-FOG AGENTS WILL DAMAGE THE COVER.¿ OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE A CORRECTION TO THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND A CORRECTION TO H4 AND H6. H4: INFORMATION ADDED TO THESE FIELDS WERE INADVERTENTLY NOT INCLUDED ON THE INITIAL MEDWATCH. H4: LOT H1Y01 MANUFACTURE DATE IS NOVEMBER 5, 2021. LOT H1Z23 MANUFACTURE DATE IS JANUARY 6, 2022. THE LEGAL MANUFACTURER PERFORMED AN INVESTIGATION. THE DEVICE HISTORY RECORDS FOR THIS DEVICE WERE REVIEWED AND ALL RECORDS INDICATED THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO ALL APPLICABLE PROCEDURES AND MET FINAL PRODUCT RELEASE CRITERIA. NO ABNORMALITIES WERE FOUND. A REPRODUCTION CONFIRMATION WAS PERFORMED ACCORDING TO THE PRE-USE INSPECTION PROCEDURE IN SECTION 7.3 OF THE INSTRUCTION MANUAL. THE INDICATED EVENT WAS NOT REPRODUCED. (MAJ-2315 LOT H1412 WAS USED FOR REPRODUCTION CONFIRMATION). THE PARTS SUPPLIER CONDUCTS SAMPLING INSPECTIONS OF THREE (3) PARTS FOR EACH PRODUCTION LOT AND CONFIRMED THE PARTS CONFORMED TO THE SPECIFICATIONS. QUALITY EVALUATIONS OF PRODUCTION PROTOTYPES HAVE VERIFIED THAT THE DISTAL COVER WILL NOT COME OFF FROM THE ENDOSCOPE UNLESS THE DISTAL COVER IS DAMAGED, AS LONG AS IT IS PROPERLY ATTACHED WITHOUT ANY DAMAGE. THE ROOT CAUSE OF THE ISSUE COULD NOT BE CONCLUSIVELY SPECIFIED. BASED ON THE REPRODUCTION CONFIRMATION RESULTS, INVESTIGATION RESULTS OF PRODUCT SPECIFICATIONS, AND THE INSPECTION RESULTS AT THE PARTS MANUFACTURER, IT IS BELIEVED THAT THE PRODUCT CONFORMED TO THE SPECIFICATIONS. HOWEVER, THE ACTUAL PRODUCT HAD NOT BEEN RETURNED, AND THE DETAILS OF THE OCCURRENCE SITUATION COULD NOT BE CONFIRMED, THEREFORE, THE CAUSE COULD NOT BE DETERMINED. THE PROBABLE CAUSE WAS LIKELY THE FOLLOWING: -CHEMICALS SUCH AS ANTI-FOG AGENTS ADHERED TO THE COVER AND WERE DAMAGED BY CHEMICAL ATTACK, MAKING IT EASY FOR THE COVER TO COME OFF THE SCOPE. THE COVER WAS EASILY REMOVED FROM THE SCOPE DUE TO INSUFFICIENT ATTACHMENT TO THE SCOPE. WHEN THE COVER WAS ATTACHED TO THE SCOPE, THE COVER WAS DAMAGED BY PUSHING IT DIAGONALLY, MAKING IT EASY FOR THE COVER TO COME OFF THE SCOPE. COMPLAINT HISTORY REVIEW: THE EVENT WAS THE FIRST OCCURRENCE AT THE FACILITY. A SIMILAR COMPLAINT FROM ANOTHER FACILITY WAS PATIENT IDENTIFIER (B)(6). THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING GUIDELINES: AS DESCRIBED IN THE IFU "7.3 ATTACHING THE DISTAL COVER" (P.11 TO P.13): PLEASE MAKE SURE THAT THE DISTAL COVER IS INTACT WITHOUT ANY PROBLEM BEFORE INSTALLATION, AND IT HAS NO DAMAGE(CRACK) AFTER INSTALLATION. ALSO, DO NOT USE ANTI-FOG AGENTS AS IT IS KNOWN THAT ANTI-FOG AGENTS WILL DAMAGE THE COVER. OLYMPUS WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 0

    THE DISTAL COVER CAME OFF OF THE ENDOSCOPE UPON WITHDRAWAL AT THE END OF THE PROCEDURE. THE DISTAL COVER WAS NOT IDENTIFIED AS MISSING AT THAT TIME. DURING THE MANUAL CLEANING PROCESS, THE STAFF IDENTIFIED THE DISTAL COVER WAS MISSING. THE SURGEON PROCEEDED TO PERFORM AN UPPER ENDOSCOPY AND LOCATED THE DISTAL COVER IN THE PATIENT¿S MOUTH BEHIND THE BITE BLOCK. THE PROCEDURAL DELAY IS UNKNOWN. (B)(6): TJF-Q190V, 2022741. (B)(6): MAJ-2315, H1Y01 OR H1Z23. THIS REPORT IS 1 OF 2 FOR (B)(6): MAJ-2315, H1Y01 OR H1Z23.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135314 SINGLE USE DISTAL COVER DISTAL COVER FDT OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT MAJ-2315 H1Y01,H1Z23 04953170403019

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown TJF-Q190V, 2022741