BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 11669514 · Received April 15, 2021

    Report

    Report Number
    8010047-2021-04966
    Event Type
    Malfunction
    Date Received
    April 15, 2021
    Date of Event
    March 23, 2021
    Report Date
    June 23, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    UDI-DI
    04953170305290
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP.(OMSC) BUT WAS RETURNED TO OLYMPUS AUSTRALIA & NEW ZEALAND (OAZ) FOR EVALUATION. OAZ INSPECTED THE DEVICE AND CONFIRMED THE FOLLOWING: THE INSULATION RESISTANCE VALUE AT THE DISTAL END WAS BELOW THE STANDARD VALUE, DUE TO THE PEELING OF THE ADHESIVE ON THE BENDING SECTION RUBBER. THE EXPECTED INSULATION PERFORMANCE WAS NOT OBTAINED, DUE TO THE CUT OF THE HEAT SHRINK TUBE OF THE UP/DOWN ANGULATION LEVER. THE DISTAL END CAP WAS DENTED. THE UPWARD ANGULATION WAS OUT OF SPECIFICATION, DUE TO THE WEAR OF THE ANGLE WIRE. THERE WERE WRINKLES ON THE INSERTION TUBE AND UNIVERSAL CORD. THE WATER SUPPLY CONNECTOR AND AIR SUPPLY CONNECTOR MOUNTS WERE LOOSE. THE IMAGE GUIDE PROTECTOR WAS CUT OFF. THE CONTROL UNIT AND S-COVER WERE DEFORMED. OAZ COULD NOT CONFIRM ANY FOREIGN MATERIAL BECAUSE IT WAS EJECTED FROM THE DEVICE DURING THE PROCEDURE. THE SIMILAR CASE HAS OCCURRED IN THE PAST AT THE USER FACILITY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED, BECAUSE THE DEVICE HAS NOT BEEN RETURNED TO OMSC. HOWEVER, BASED UPON THE PAST SIMILAR CASES, THE REPORTED EVENT MAY HAVE BEEN CAUSED BY A FOREIGN MATERIAL REMAINING INSIDE THE INSTRUMENT CHANNEL DUE TO INADEQUATE CLEANING OF THE INSTRUMENT CHANNEL. THE INSTRUCTION MANUAL STATES THAT WHEN BRUSHING EACH CHANNEL, BRUSHING IS PERFORMED UNTIL THERE IS NO RESIDUE. DEVICE HISTORY RECORD (DHR) REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE IN THIS REPORT HAS NOT BEEN RETURNED TO OMSC FOR EVALUATION. ADDITIONAL INFORMATION PROVIDED BY THE SALES REPRESENTATIVE CONFIRMED THE FOLLOWING: THE DEVICE WAS USED FOR GASTROSCOPY BEFORE THE REPORTED EVENT OCCURRED. THE DEVICE WAS THEN REPROCESSED WITH A NON-OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR, SOLUSCOPE. A NON-OLYMPUS CHANNEL CLEANING BRUSH WAS USED TO CLEAN THE ENDOSCOPE. THE USER FACILITY ONLY BRUSHED FOR PATENCY WHILE CLEANING THE DEVICE. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE USER THAT A HUMAN BODY TISSUE CAME OUT OF THE INSTRUMENT CHANNEL OF THE DEVICE WHILE THE USER WAS INSERTING A ENDOTHERAPY ACCESSORY INTO IT. THE TISSUE DIDN'T APPEAR TO COME FROM THE PATIENT UNDERGOING THE PROCEDURE. THE TISSUE WAS RETRIEVED FROM THE PATIENT. THE DEVICE WAS USED WITH ENDOTHERAPY ACCESSORIES AND A NON-OLYMPUS SINGLE USE BIOPSY VALVE. THE USER REPLACED THE DEVICE TO THE NEW GASTROSCOPE AND COMPLETED THE PROCEDURE. A BLOOD TEST WAS DONE BEFORE THE PATIENT WAS DISCHARGED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572798 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-H190 04953170305290

    Patients

    Seq Age Sex Outcome Treatment
    1