BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 11989234 · Received June 13, 2021

    Report

    Report Number
    8010047-2021-07449
    Event Type
    Malfunction
    Date Received
    June 13, 2021
    Report Date
    August 2, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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 DEUTSCHLAND GMBH (ODE). ODE INSPECTED THE DEVICE AND CONFIRMED THE FOLLOWING: -THERE WAS A DEFECT IN THE PIXELS OF THE ENDOSCOPIC IMAGE. -THE CONTACTS OF THE ENDOSCOPE CONNECTOR WERE SLIGHTLY DEFORMED. -THE COATING OF THE UNIVERSAL CORD WAS SLIGHTLY DAMAGED. ODE MADE CONSCIENTIOUS EFFORTS, BUT WAS NOT ABLE TO OBTAIN INFORMATION ABOUT THE REPROCESS METHOD AND A RESULT OF MICROBIOLOGICAL TESTING FROM THE USER FACILITY. OMSC COULD NOT CONFIRM ANY DEFECTS THAT COULD CAUSE THE REPORTED EVENT FROM THE DEVICE INSPECTION RESULT BY ODE. THE INSTRUCTION MANUAL STATES THE POSSIBILITY OF INFECTION BY INSUFFICIENT REPROCESSING. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED, BECAUSE THE RESULT OF MICROBIOLOGICAL TESTING CONDUCTED BY THE THIRD PARTY LABORATORY AFTER REPROCESSING BY ODE CLEARED THE GERMAN GUIDELINE. HOWEVER, BASED UPON THE PAST SIMILAR CASES, THE REPORTED EVENT MAY HAVE BEEN CAUSED BY THE FOLLOWING: -THERE WAS A DIFFERENCE IN THE REPROCESSING METHOD OF THE DEVICE PERFORMED BY THE USER FACILITY AND ODE. -CONTAMINATION OCCURRED DURING SAMPLE COLLECTION FOR MICROBIOLOGICAL TESTING. 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 · 0

    THE DEVICE HAS NOT BEEN RETURNED TO OMSC BUT WAS RETURNED TO OLYMPUS (B)(4). SENT THE DEVICE TO A THIRD PARTY LABORATORY FOR MICROBIOLOGICAL TESTING. AS A RESULT OF THE TESTING, NO MICROBE WAS DETECTED FROM THE SAMPLE COLLECTED FROM THE DISTAL END AND THE INSTRUMENT, THE AIR/WATER CHANNELS OF THE DEVICE. THE TESTING RESULT CLEARED THE GERMAN GUIDELINE. 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 · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT AS A RESULT OF MULTIPLE MICROBIOLOGICAL TESTING BY THE USER FACILITY, THE SAMPLE COLLECTED FROM SUCTION CHANNEL OF THE DEVICE TESTED THREE TIMES POSITIVE FOR UNSPECIFIED BACTERIA. THE USER FACILITY DID NOT PROVIDE OTHER DETAILED INFORMATION SUCH AS THE NUMBER AND THE TYPE OF BACTERIA. OTHER DETAILED INFORMATION SUCH AS THE REPROCESSING METHOD WAS NOT PROVIDED. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885415 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-H185

    Patients

    Seq Age Sex Outcome Treatment
    1