BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III BRONCHOVIDEOSCOPE

    MDR report key: 24802093 · Received April 7, 2026

    Report

    Report Number
    9610595-2026-28057
    Event Type
    Malfunction
    Date Received
    April 7, 2026
    Date of Event
    January 7, 2026
    Report Date
    April 13, 2026
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    EOQ
    UDI-DI
    04953170342110
    PMA / PMN Number
    K250862
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT WAS SUBMITTED TO PROVIDE A CORRECTION TO THE PREVIOUSLY SUBMITTED H11 INFORMATION PROVIDED. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION WHERE THE REPORTED FAILURE WAS IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, A ROOT CAUSE COULD NOT BE IDENTIFIED. THE MOST PROBABLE CAUSE OF THE COMPLAINT IS D02 - CAUSE TRACED TO COMPONENT FAILURE EXPECTED OR RANDOM COMPONENT FAILURE WITHOUT ANY DESIGN OR MANUFACTURING ISSUE. DUE TO C0601 - DEGRADATION PROBLEM IDENTIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS REPORTED BECAUSE TORN AT END. THIS SCOPE WAS JUST REPAIRED FOR SAME ISSUE AND HAPPENED WITH FIRST USE UPON RETURN. THE PRODUCT WAS RETURNED TO THE OLYMPUS SERVICE TEAM. THE PRODUCT ANALYSIS CONFIRMED THAT 1. D/E PLASTIC CV : MISSING - A0501 - DETACHMENT OF DEVICE OR DEVICE COMPONENT - G04037 - COVER. 2. A-RUBBER : MISSING HALF - A0501 - DETACHMENT OF DEVICE OR DEVICE COMPONENT - G04037 - COVER. 3. A-RUBBER GLUE: MISSING - A0501 - DETACHMENT OF DEVICE OR DEVICE COMPONENT - G0405201 - ADHESIVE. 4. OB LENS: MISSING - A0501 - DETACHMENT OF DEVICE OR DEVICE COMPONENT - G05006 - LENSES. 5. LG LENS: MISSING - A0501 - DETACHMENT OF DEVICE OR DEVICE COMPONENT - G05006 - LENSES. 6. BENDING SECTION: MISSING - A0501 - DETACHMENT OF DEVICE OR DEVICE COMPONENT - G04134 - TUBE. 7. ANGULATION: A150201 - POSITIONING FAILURE - G04121 - STEERING WIRE. 8. CONTROL KNOB: TOTAL UP AND DOWNPLAY - A051207 - UNSTABLE - G04079 - KNOB. 9. CTRL KNOB MOV: TOTAL PLAY UP AND DOWN - A051207 - UNSTABLE - G04079 - KNOB. ONE OR MORE FAILURE MODE(S) IDENTIFIED HAS BEEN PREVIOUSLY INVESTIGATED THROUGH THE PRODUCT TECHNICAL INVESTIGATION (PTI) PROCESS AND THEREFORE DOES NOT REQUIRE ANY FURTHER INVESTIGATION. SEE CODING TABLE FOR THE PTI REFERENCE NUMBER ASSOCIATED WITH THESE FAILURE MODES. A SHR REVIEW WAS NOT CONDUCTED ON THIS PREVIOUSLY SERVICED DEVICE AS THERE IS NO PACKAGING ISSUE, INCORRECT LABELING ISSUE, OR DAMAGES TRACED TO PRIOR REPAIR ACTIVITIES. A LABELING REVIEW IS NOT REQUIRED AS THERE IS NO EVIDENCE TO SUGGEST THAT THE USER MAY NOT HAVE PROPERLY HANDLED/USED THE DEVICE IN ACCORDANCE WITH THE IFU. AA RISK REVIEW WAS PERFORMED ON 23 MAR 2026 FOR THE FAILURES LISTED BELOW, BASED ON HISTORICAL COMPLAINT DATA AND NO UNANTICIPATED RISKS, NEW FAILURES, AND/OR NEW HARMS WERE IDENTIFIED. 1. D/E PLASTIC CV: MISSING - A0501 - DETACHMENT OF DEVICE OR DEVICE COMPONENT - G04037 - COVER. 2. A-RUBBER GLUE: MISSING - A0501 - DETACHMENT OF DEVICE OR DEVICE COMPONENT - G0405201 - ADHESIVE. 3. OB LENS: MISSING - A0501 - DETACHMENT OF DEVICE OR DEVICE COMPONENT - G05006 - LENSES. 4. BENDING SECTION: MISSING - A0501 - DETACHMENT OF DEVICE OR DEVICE COMPONENT - G04134 - TUBE. 5. CONTROL KNOB: TOTAL UP AND DOWNPLAY - A051207 - UNSTABLE - G04079 - KNOB. 6. TORN AT END. - A0414 - MATERIAL SPLIT, CUT OR TORN - G04129 - TIP. A COMPLAINT HISTORY REVIEW WAS PERFORMED ON 23 MAR 2026 FOR THE LAST TWELVE MONTHS 24 MAR 2025 - 23 MAR 2026 FOR THE FAILURE MODES LISTED BELOW AND NO TRENDS WERE IDENTIFIED. 1. D/E PLASTIC CV : MISSING - A0501 - DETACHMENT OF DEVICE OR DEVICE COMPONENT - G04037 - COVER THE COMPLAINT RATE IS 1 WHICH DOES NOT EXCEED THE UCL OF 8.9. 2. A-RUBBER GLUE: MISSING - A0501 - DETACHMENT OF DEVICE OR DEVICE COMPONENT - G0405201 - ADHESIVE. THE COMPLAINT RATE IS 1 WHICH DOES NOT EXCEED THE UCL OF 8.9. 3. OB LENS : MISSING - A0501 - DETACHMENT OF DEVICE OR DEVICE COMPONENT - G05006 - LENSES THE COMPLAINT RATE IS 1 WHICH DOES NOT EXCEED THE UCL OF 8.9. 4. BENDING SECTION: MISSING - A0501 - DETACHMENT OF DEVICE OR DEVICE COMPONENT - G04134 - TUBE. THE COMPLAINT RATE IS 1 WHICH DOES NOT EXCEED THE UCL OF 8.9. 5. CONTROL KNOB : TOTAL UP AND DOWN PLAY - A051207 - UNSTABLE - G04079 - KNOB THE COMPLAINT RATE IS 0 WHICH DOES NOT EXCEED THE UCL OF 5.5. 6. TORN AT END. - A0414 - MATERIAL SPLIT, CUT OR TORN - G04129 - TIP THE COMPLAINT RATE IS 0 WHICH DOES NOT EXCEED THE UCL OF 47.74. A CAPA HISTORY REVIEW WAS PERFORMED ON 23 MAR 2026 FOR THE FAILURE MODES LISTED BELOW AND NO RELATED CAPAS WERE FOUND. THIS REVIEW WAS PERFORMED FOR BF-P190 AND ADDITIONAL SEARCHED TERMS MISSING, UNSTABLE AND CUT. 1. D/E PLASTIC CV: MISSING - A0501 - DETACHMENT OF DEVICE OR DEVICE COMPONENT - G04037 - COVER. 2. A-RUBBER GLUE: MISSING - A0501 - DETACHMENT OF DEVICE OR DEVICE COMPONENT - G0405201 - ADHESIVE. 3. OB LENS: MISSING - A0501 - DETACHMENT OF DEVICE OR DEVICE COMPONENT - G05006 - LENSES 4. BENDING SECTION : MISSING - A0501 - DETACHMENT OF DEVICE OR DEVICE COMPONENT - G04134 - TUBE. 5. CONTROL KNOB : TOTAL UP AND DOWN PLAY - A051207 - UNSTABLE - G04079 - KNOB. 6. TORN AT END. - A0414 - MATERIAL SPLIT, CUT OR TORN - G04129 - TIP. THE COMPLAINT WAS CONFIRMED, THE DEVICE HAS D/E MISSING, INCLUDING C-COVER.LG AND OB LENS. THE MOST PROBABLE CAUSE OF THE COMPLAINT IS D02 - CAUSE TRACED TO COMPONENT FAILURE EXPECTED OR RANDOM COMPONENT FAILURE WITHOUT ANY DESIGN OR MANUFACTURING ISSUE. DUE TO C0601 - DEGRADATION PROBLEM IDENTIFIED PROBLEMS THAT OCCUR WHEN THE DEVICE BECOMES WORN, WEAKENED, CORRODED, OR BROKEN DOWN DUE TO PROCESSES SUCH AS AGING, PERMEATION, AND CORROSION. NO FURTHER ESCALATION IS REQUIRED.

    Description of Event or Problem · 0

    THERE IS NO NEW INFORMATION PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 0

    THE BRONCHOVIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF A TEAR AT THE END. THIS DOES NOT INDICATE A REPORTABLE EVENT. HOWEVER, A REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, IT WAS OBSERVED THAT THE DISTAL END COVER IS MISSING, THE OBJECTIVE LENS IS MISSING, AND THE LIGHT GUIDE LENS IS MISSING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867190 EVIS EXERA III BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ AIZU OLYMPUS CO., LTD. BF-P190 04953170342110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown