BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 13581811 · Received February 22, 2022

    Report

    Report Number
    8010047-2022-03390
    Event Type
    Malfunction
    Date Received
    February 22, 2022
    Date of Event
    January 17, 2022
    Report Date
    May 18, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    UDI-DI
    04953170305290
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER HMI (HYGIENE MICROBIOLOGICAL INVESTIGATION) RESULTS REPORTED THE DEVICE (ALL CHANNELS) TESTED POSITIVE WITH PSEUDOMONAS AERUGINOSA (4 CFU/100 ML). THE OFR (OLYMPUS FRANCE) FRENCH OLYMPUS SUBSIDIARY FOR HMI (HYGIENE MICROBIOLOGICAL INVESTIGATION) PERFORMED A CULTURE TEST FOR THE DEVICE AFTER THE DEVICE WAS REPROCESSED . THE OFR HMI (HYGIENE MICROBIOLOGICAL INVESTIGATION) RESULTS REPORTED THE ENDOSCOPE DEVICE CHANNEL (ALL CHANNELS) CONFORMS, WITH RESULTS OF LESS THAN 1 CFU PER 100/ML AND LESS THAN 1 CFU/ENDOSCOPE). OFR (OLYMPUS FRANCE) FRENCH OLYMPUS SUBSIDIARY FOR HMI (HYGIENE MICROBIOLOGICAL INVESTIGATION) RESULTS OBTAINED COMPLY WITH THE TARGET LEVEL DEFINED IN THE REGULATIONS OF FRANCE OUTLINED ON JULY 4, 2016. THE RESULTS ARE CONFORM TO FRENCH RECOMMENDATION. THE RRC (REGIONAL REPAIR CENTER) FRANCE OLYMPUS DEVICE EVALUATION FINDINGS ARE NOT YET AVAILABLE FOR REVIEW. THE CUSTOMER CDS CHECKLIST HAS NOT YET BEEN RECEIVED. FOLLOW UPS ARE IN PROGRESS. 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 DEVICE EVALUATION AND CUSTOMER CDS CHECKLIST FOLLOW UP UPDATES. MULTIPLE FOLLOW UPS WERE MADE TO OBTAIN THE CUSTOMER CDS CHECKLIST HOWEVER, WERE UNSUCCESSFUL, NO RESPONSE RECEIVED FROM THE CUSTOMER. RRC (REGIONAL REPAIR CENTER) FRANCE OLYMPUS DEVICE EVALUATION FINDINGS ARE BELOW: BENDING SECTION (A-RUBBER) GLUE CRACKED, SEPARATED. LEAK ON CONTROL UNIT (SCOPE COVER) INSULATION D/E VALUE RESISTANCE OUT OF SPECIFICATION. LIGHT GUIDE ROD LENS WERE CRACKED, SWITCH SECTION KEY TOP CUT CONNECTING TUBE WRINKLED. CONTROL UNIT CRACKED AND ANGULATION ARE OUT OF SPECIFICATIONS. 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 AND 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, A ROOT CAUSE COULD NOT BE DETERMINED. GROWTH OF MICROORGANISMS WERE FOUND THROUGH CULTURE TESTING BY THE USER AFTER REPROCESSING. HOWEVER, WHEN OLYMPUS CULTURE TESTED AFTER REPROCESSING IN ACCORDANCE WITH INSTRUCTIONS FOR USE (IFU) BEFORE REPAIR, THE RESULTS CONFORMED TO THE REGULATION'S RECOMMENDATION. THE FOLLOWING IS INCLUDED IN THE DEVICE IFU: "WARNING: AN INSUFFICIENTLY REPROCESSED ENDOSCOPE AND/OR ACCESSORY MAY POSE AN INFECTION CONTROL RISK TO THE PATIENTS AND/OR OPERATORS WHO TOUCH THEM." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    AS REPORTED, AFTER A MICROBIOLOGICAL ROUTINE CONTROL TEST ON THE SUBJECT MEDICAL DEVICE AS REQUIRED BY FRENCH REGULATION, THE USER DETECTED AN UNEXPECTED CONTAMINATION. THE ISSUE FOUND DURING REPROCESSING. THE USER THEN SENT THE DEVICE TO THE OFR (OLYMPUS FRANCE) FRENCH OLYMPUS SUBSIDIARY FOR HMI (HYGIENE MICROBIOLOGICAL INVESTIGATION) FOR FURTHER INVESTIGATION. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY PATIENT INJURY OR PATIENT INFECTION TO WHICH THIS MEDICAL DEVICE COULD HAVE BEEN A CONTRIBUTORY CAUSE. NO USER INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847780 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-H190 04953170305290

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown