BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 12737375 · Received November 2, 2021

    Report

    Report Number
    8010047-2021-13961
    Event Type
    Malfunction
    Date Received
    November 2, 2021
    Date of Event
    September 24, 2021
    Report Date
    February 7, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    ODG
    UDI-DI
    04953170356339
    PMA / PMN Number
    K093395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    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, THE CAUSE OF THE FORCEPS COVER GLUE PEELING LIKELY OCCURRED DUE TO AN EXTERNAL FORCE APPLIED TO THE DISTAL END. THE SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. THE FOLLOWING INFORMATION IS STATED IN THE INSTRUCTIONS FOR USE WHICH MAY HAVE PREVENTED THE EVENT: "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." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE CUSTOMER¿S ALLEGATION WAS CONFIRMED. THE DEVICE EVALUATION DETERMINED THE SUBJECT DEVICE HAD A LEAK IN THE ELEVATOR CHANNEL FROM THE BODY CONTROL UNIT (BCU) SIDE AND THE INLET WAS LOOSE. IN ADDITION, THERE WAS PEELING GLUE ON THE FORCEPS COVER, BROKEN ELEMENTS ON THE ULTRASOUND IMAGE, THE BUTTON ON THE SWITCH WAS CUT AND NOT FUNCTIONING, A MISSING PLATE ON THE BCU SIDE COVER, A COLLAPSED LIGHT GUIDE TUBE, A WATER STAIN ON THE SCOPE CONNECTOR, CONNECTOR CORROSION AND HEAVY TENSION ON THE RIGHT LEFT KNOB OF THE CONTROL KNOB. THE EVALUATION ALSO FOUND THE DEVICE HAD BEEN REPAIRED USING NON-OLYMPUS BENDING SECTION COVER AND BENDING SECTION COVER ADHESIVE. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO OLYMPUS, THE EXIS EXERA II ULTRASOUND GASTROVIDEOSCOPE FAILED THE LEAK TEST DURING REPROCESSING. THE CUSTOMER THINKS THE USER FACILITY USES A MEDIVATOR LEAK TESTER. THE DEVICE IS LEAK TESTED AFTER EVERY USE. THE UNKNOWN PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. DURING THE INSPECTION OF THE RETURNED DEVICE, THE GLUE ON THE FORCEPS COVER WAS FOUND TO BE PEELING. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1638730 EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG OLYMPUS MEDICAL SYSTEMS CORP. GF-UCT180 04953170356339

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown