BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 16661556 · Received April 3, 2023

    Report

    Report Number
    9610595-2023-05465
    Event Type
    Malfunction
    Date Received
    April 3, 2023
    Date of Event
    March 6, 2023
    Report Date
    May 5, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    UDI-DI
    04953170305276
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION REGARDING THE EVENT REPORTED AND RESPONSE TO FOLLOW UP. COMMUNICATION WITH SERVICE BUSINESS CENTER CONVEYED THAT THE DEVICE WAS DISCOVERED WET AT OLYMPUS BUSINESS CENTER, OBV. NO HYGIENE MICROBIOLOGICAL INVESTIGATION (HMI) WAS DONE. PER THE REPORT, THE CLEANING STERILIZATION AND DISINFECTION (CDS) OF THE DEVICE HAS BEEN DONE BY THE REPAIR CENTER AT OLYMPUS HAMBURG. 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 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 AND BECAUSE THE SUBJECT DEVICE WAS NOT RETURNED, A ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER IT IS LIKELY THAT ONE OF THE FOLLOWING CAUSED THE EVENT: - WORK AT THE WATER DRAIN PROCESS MAY HAVE BEEN INADEQUATE. - WATER DRAINING PROCESS FROM THE DEVICE AT REPAIR CENTER WAS INCOMPLETE. - THERE WAS DEFECT IN THE JIG THAT WAS USED IN THE WATER REMOVAL PROCESS, AIR PRESSURE WAS NOT WITHIN THE SPECIFICATION VALUE, ETC. THE SUGGESTED EVENT IS PREVENTABLE BY HANDLING THE DEVICE IN ACCORDANCE WITH THE FOLLOWING INSTRUCTIONS FOR USE (IFU): ¿IMPROPER STORAGE PRACTICES, SUCH AS NOT THOROUGHLY DRYING EXTERNAL AND INTERNAL SURFACES (LUMENS) PRIOR TO STORAGE, WILL LEAD TO AN INFECTION CONTROL RISK.¿ ¿WHEN AERATING THE ENDOSCOPE CHANNELS, THE AIR PRESSURE USED FOR MANUAL DRYING SHOULD BE 0.2 MPA OR MORE BUT LESS THAN 0.5 MPA (=2 AND <5 KGF/CM2, =29 AND <72 PSIG). HIGHER PRESSURES MAY CAUSE DAMAGE TO THE ENDOSCOPE.¿ OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION. IN ADDITION, FOLLOW UP IS IN PROGRESS TO GATHER ADDITIONAL INFORMATION REGARDING THE EVENT REPORTED. SUPPLEMENTAL REPORT(S) WILL BE SUBMITTED SHOULD ANY RELEVANT NEW INFORMATION IS AVAILABLE AND OR RECEIVED. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Description of Event or Problem · 0

    COMPANY REPRESENTATIVE REPORTED THE DEMO DEVICE WAS RECEIVED AND FOUND THERE WAS NORMAL TAPWATER IN THE AIR/WATER CHANNEL. IT WAS STATED THIS IS A HYGIENE RISK SINCE THE TAP WATER CONTAINING BACTERIA CAN RESULT IN BIOFILM FORMATION WHICH ARE HARD TO REMOVE. NO REPORT OF ANY CONTAMINATION OR ANY PATIENT INJURY OR PATIENT INFECTION TO WHICH THIS MEDICAL DEVICE COULD HAVE BEEN A CONTRIBUTORY CAUSE. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THIS EVENT. NO HARM WAS REPORTED, NO USER INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878698 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-HQ190 04953170305276

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown