BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 13155364 · Received January 4, 2022

    Report

    Report Number
    8010047-2022-00840
    Event Type
    Malfunction
    Date Received
    January 4, 2022
    Report Date
    February 11, 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
    NY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RECEIVED AND EVALUATED. INSPECTION FOUND THE REPORTED CUSTOMER ISSUE OF "NO PROBE CONNECTION " WAS NOT ABLE TO BE DUPLICATED AS THERE WAS NO ISSUE FOUND ON THE PROBE UNIT HOWEVER, PEELING ON THE FORCEPS COVER GLUE , DENT ON THE C-BODY (CONTROL BODY) AFFECTING THE FUNCTION WAS IDENTIFIED. FURTHER INSPECTION FOUND THE FOLLOWING DEFECTS ON THE DEVICE: A-RUBBER GLUE: FOUND CHIPPED, UM IMAGE FOUND WITH ONE BROKEN ELEMENT, SWITCH/CAMERA CUTS FOUND ON SW (SWITCH BUTTON) #1, ELEVATOR CH W/F INLET FOUND LOOSE, SCOPE CONN A/W (AIR/WATER) INLET FOUND LOOSE, LEAKING, ELEVATOR INSULATION (EL) FOUND WITH FLUID INVASION, UM CONNECTOR: FOUND WITH FLUID INVASION, CONTROL KNOB MV: FOUND WITH LOW TENSION, INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 3 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE LEGAL MANUFACTURER'S INVESTIGATION, THE ROOT CAUSE OF THE FORCEPS COVER GLUE PEELING COULD NOT BE IDENTIFIED. HOWEVER, IT IS POSSIBLE THE CAUSE WAS RELATED TO SOME KIND OF EXTERNAL FORCE THAT WAS APPLIED TO THE RELEVANT PART. PER THE INSTRUCTIONS FOR USE: INSPECT THE EXTERNAL SURFACE OF THE ENTIRE INSERTION SECTION INCLUDING THE BENDING SECTION AND THE DISTAL END FOR DENTS, BULGES, SWELLING, SCRATCHES, 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

    AS REPORTED, DURING AN UNKNOWN EVENT, NO CONNECTION PROBE FOUND ON THE DEVICE. THERE IS NO PATIENT INVOLVEMENT ASSOCIATED ON THIS REPORTED EVENT. NO USER INJURY REPORTED. DEVICE RETURN EVALUATION FOUND FORCEPS COVER GLUE PEELING. THIS EVENT IS BEING SUBMITTED, REPORTED DUE TO FORCEPS COVER GLUE PEELING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1192821 EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG OLYMPUS MEDICAL SYSTEMS CORP. GF-UCT180 04953170356339

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown