BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 20124272 · Received September 3, 2024

    Report

    Report Number
    3002808148-2024-08332
    Event Type
    Malfunction
    Date Received
    September 3, 2024
    Date of Event
    August 23, 2024
    Report Date
    September 24, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    ODG
    UDI-DI
    04953170356346
    PMA / PMN Number
    K093395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. CORRECTED FIELDS: B3 (EVENT DATE IS UNKNOWN) AND B5 (EVALUATION RESULT FOR PAE DETERMINATION HAS TO BE REMOVED FROM B5 IN INITIAL MEDWATCH). H6 MEDICAL DEVICE PROBLEM CODE. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 9 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, A ROOT CAUSE FOR GAP BETWEEN THE ACOUSTIC LENS AND THE ULTRASOUND PROBE COULD NOT BE IDENTIFIED. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE: DO NOT COIL THE INSERTION TUBE OR UNIVERSAL CORD WITH A DIAMETER OF LESS THAN 12 CM. EQUIPMENT DAMAGE CAN RESULT. DO NOT ATTEMPT TO BEND THE ENDOSCOPE¿S INSERTION SECTION WITH EXCESSIVE FORCE. OTHERWISE, THE INSERTION SECTION MAY BE DAMAGED. DO NOT APPLY SHOCK TO THE DISTAL END OF THE INSERTION SECTION, PARTICULARLY THE ULTRASOUND TRANSDUCER AND THE OBJECTIVE LENS SURFACE AT THE DISTAL END. VISUAL ABNORMALITIES MAY RESULT. DO NOT TWIST OR BEND THE BENDING SECTION WITH YOUR HANDS. EQUIPMENT DAMAGE MAY RESULT. DO NOT SQUEEZE THE BENDING SECTION FORCEFULLY. THE COVERING OF THE BENDING SECTION MAY STRETCH OR BREAK AND CAUSE WATER LEAKS. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE GASTRO VIDEOSCOPE HAD A GAP BETWEEN THE ACOUSTIC LENS AND THE ULTRASOUND PROBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT. [PRIMARY EVALUATION FOR PAE DETERMINATION]: EVALUATION DATE: 2024/8/27. EVALUATOR: (B)(4). PURPOSE OF PROCEDURE: UNKNOWN. AT THIS TIME, THE EVALUATION TAB IS NOT AVAILABLE. THEREFORE PRIMARY EVALUATION IS DESCRIBED AT EVENT DESCRIPTION. TEMPORARILY. -INTAKE INFORMATION- EVENT1: SCOPE CONNECTOR LABEL PEELS OFF. INTAKE CODE: GIE3002. PAE JUDGMENT: NON-PAE. TIER CLASSIFICATION: TIER3 . INVESTIGATION: UNNECESSARY. EVENT2: CONTROL UNIT IS DAMAGED. INTAKE CODE: GIE4207. PAE JUDGMENT: NON-PAE. TIER CLASSIFICATION: TIER3. INVESTIGATION: UNNECESSARY. -DEVICE EVALUATION- EVENT1: UNABLE TO CONFIRM - SCOPE CONNECTOR LABEL PEELS OFF. UNIVERSAL FAILURE CODE: GIE3002. PAE JUDGMENT: NON-PAE. TIER CLASSIFICATION: TIER3.. INVESTIGATION: UNNECESSARY. EVENT2: GRIP IS DEFORMED. UNIVERSAL FAILURE CODE: GIE4207A. PAE JUDGMENT: NON-PAE. TIER CLASSIFICATION: TIER3. INVESTIGATION: UNNECESSARY. EVENT3: THERE IS A GAP BETWEEN ACOUSTIC LENS AND ULTRASOUND PROBE. UNIVERSAL FAILURE CODE: GIE2332Y. PAE JUDGMENT: PAE-YES. TIER CLASSIFICATION: TIER2. INVESTIGATION: NECESSARY. CONTAINMENT: NOT REQUIRED BECAUSE THERE IS NOT FACT OR POSSIBILITY INDICATING EVENT MIGHT SPREAD ANY FURTHER. THE OTHER EVENTS ARE TIER3, INVESTIGATION UNNECESSARY (AS FOLLOWS). DUE TO WEAR OF FE LEVER, U/D KNOB CANNOT BE LOCKED SECURELY.(GIB1102A). S-BODY HAS A CRACK.(GIE4207A). SWITCH BOX HAS A SCRATCH.(GIE4123A). S-COVER PLATE IS UNCLEAR.(GIE4206Y). T-NUT IS LOOSE.(GIE4401B). DUE TO DAMAGE ON A-RUBBER, INSULATION RESISTANCE VALUE AT DISTAL END DOES NOT MEET THE STANDARD VALUE.(GIT0002B). DUE TO DAMAGE ON ULTRASONIC PROBE, DISPLAYED ULTRASOUND IMAGE IS DEFECTIVE WITH MISSING ELEMENTS.(GIU1401Y). ADHESIVE AROUND LG LENS HAS WEAR.(GIE2335Y). ADHESIVE ON A-RUBBER HAS WEAR.(GIB2111B) . DUE TO WEAR OF ANGLE WIRE, THE PLAY OF U/D KNOB IS OUT OF THE STANDARD VALUE.(GIB1221A). ULTRASONIC PROBE IS LOOSE.(GIU6007A).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1369615 EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG SHIRAKAWA OLYMPUS CO., LTD. GF-UCT180 04953170356346

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown