BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE

    MDR report key: 11704539 · Received April 21, 2021

    Report

    Report Number
    8010047-2021-05209
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Report Date
    May 3, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    GCJ
    UDI-DI
    04953170310386
    PMA / PMN Number
    K111425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INVESTIGATION RESULTS AND CORRECT SECTIONS. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. A DEFINITIVE ROOT CAUSE OF THE FOGGY IMAGE COULD NOT BE DETERMINED; HOWEVER, THE FOGGY IMAGE WAS LIKELY CAUSED BY MOISTURE ENTERING THE DEVICE THROUGH THE VIDEO CONNECTOR. IT'S POSSIBLE THAT MOISTURE REACHED THE CHARGED COUPLED DEVICE (CCD) CAUSING THE ISSUE. THE CUSTOMER MAY BE ABLE TO REDUCE AND PREVENT OCCURRENCE OF THE EVENT BY HANDLING DEVICE IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). PERFORM THE LEAKAGE TEST: CAUTION. WHEN ATTACHING THE CONNECTOR CAP OF THE LEAKAGE TESTER TO THE VENTING CONNECTOR OF THE ENDOSCOPE, MAKE SURE THAT BOTH THE CONNECTOR CAP AND THE VENTING CONNECTOR ARE THOROUGHLY DRY. WATER ON THE SURFACE OF EITHER COMPONENT MAY ENTER THE ENDOSCOPE AND COULD CAUSE ENDOSCOPE DAMAGE. DO NOT ATTACH/DETACH THE LEAKAGE TESTER WHILE IMMERSED. ATTACHING/DETACHING UNDER WATER COULD ALLOW THE WATER TO ENTER THE ENDOSCOPE, RESULTING IN ENDOSCOPE DAMAGE. 5.1 TROUBLESHOOTING: IF ANY IRREGULARITY IS OBSERVED DURING THE INSPECTION DESCRIBED IN CHAPTER 3, ¿PREPARATION AND INSPECTION¿, DO NOT USE THE ENDOSCOPE AND SOLVE THE PROBLEM AS DESCRIBED IN SECTION 5.2, ¿TROUBLESHOOTING GUIDE¿. IF THE PROBLEM STILL CANNOT BE RESOLVED, SEND THE ENDOSCOPE TO OLYMPUS FOR REPAIR AS DESCRIBED IN SECTION 5.4, ¿RETURNING THE ENDOSCOPE FOR REPAIR¿. ALSO, SHOULD ANY IRREGULARITY BE OBSERVED WHILE USING THE ENDOSCOPE, STOP USING IMMEDIATELY AND WITHDRAW THE ENDOSCOPE FROM THE PATIENT AS DESCRIBED SECTION 5.3, ¿WITHDRAWAL OF THE ENDOSCOPE WITH AN IRREGULARITY¿. IF ADDITIONAL INFORMATION BECOMES AVAILABLE AT A LATER DATE, THIS REPORT WILL BE SUPPLEMENTED. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO CORRECT THE LEGAL MANUFACTURER¿S CONTACT INFORMATION AND FACILITY REGISTRATION NUMBER. THE FACILITY REGISTRATION NUMBER IS (B)(4).

    Additional Manufacturer Narrative · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WILL START EVALUATING THE DEVICE. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) COULD NOT INVESTIGATE THE SUBJECT DEVICE, BECAUSE THE SUBJECT DEVICE WAS NOT RETURNED TO OMSC. DEVICE HISTORY RECORD REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. THE OLYMPUS LOCAL SERVICE DEPARTMENT REPORT THAT THE VIDEO CONNECTOR OF THE SUBJECT DEVICE WAS LEAKAGE. SINCE THE SUBJECT DEVICE WAS NOT RETURNED TO OMSC, THE EXACT CAUSE WAS UNKNOWN. BASED UPON THE INFORMATION FROM THE OLYMPUS LOCAL SERVICE DEPARTMENT, OMSC SURMISED THAT THE REPORTED PHENOMENON OCCURRED DUE TO THE FOLLOWING CAUSE. THE IMAGE OUTPUT BECAME UNSTABLE SINCE A TEMPORARY SHORT CIRCUIT CAUSED BY THE WATER INVASION IN THE VIDEO CONNECTOR.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT DURING THE PROCEDURE WITH THE SUBJECT DEVICE, THE SCREEN SHOWED NOISE AND THE ENDOSCOPIC IMAGE WAS INVISIBLE. THE SUBJECT DEVICE WAS RETURNED TO THE OLYMPUS LOCAL SERVICE DEPARTMENT. THE OLYMPUS LOCAL SERVICE DEPARTMENT CHECKED THE SUBJECT DEVICE AND FOUND THAT THE REPORTED PHENOMENON COULD NOT BE DUPLICATED. OTHER DETAILED INFORMATION WAS NOT PROVIDED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596031 ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE FLEX DEFLECTABLE VIDEOSCOPE GCJ AIZU OLYMPUS CO., LTD. LTF-S190-10 04953170310386

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown