BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA ELITE II VIDEO SYSTEM CENTER

    MDR report key: 19244134 · Received May 3, 2024

    Report

    Report Number
    3002808148-2024-04139
    Event Type
    Malfunction
    Date Received
    May 3, 2024
    Date of Event
    April 26, 2024
    Report Date
    May 31, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170386022
    PMA / PMN Number
    K200542
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IN SPEAKING WITH THE OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC), THE CUSTOMER REQUESTED FOR TROUBLESHOOTING STEPS TO RESOLVE THE ISSUE OVER THE PHONE. THEY ALSO MENTIONED HAVING OPENED A REPAIR RMA FOR THE UNIT THE PREVIOUS WEEK AND INDICATED THAT A SECOND UNIT WAS EXPERIENCING SIMILAR SYMPTOMS THAT MORNING, REFERENCE CASE 20240429 -1895758. THE CUSTOMER WAS INFORMED BY A CUSTOMER SERVICE REPRESENTATIVE THAT WERE NO LOANERS AVAILABLE. AND HE SUGGESTED BY CUSTOMER SERVICE REPRESENTATIVE THAT THERE ARE NO LOANERS AVAILABLE. THEY INQUIRED ABOUT ALTERNATIVE TROUBLESHOOTING STEPS. IT WAS CONFIRMED THAT THE ISSUE WAS OCCURRING WITH MULTIPLE SCOPES, AS THE CUSTOMER MENTIONED IT WAS HAPPENING WITH SIX DIFFERENT CAMERA HEADS. THE CUSTOMER WAS INSTRUCTED TO CLEAN THE CONTACTS IN THE OTV -S300 SOCKET WITH CANNED AIR AND 70% ETHYL OR ISOPROPYL ALCOHOL WITH A LINT -FREE CLOTH AND CONNECT THE SCOPES AGAIN. IF THE ERROR STILL OCCURS, THE OTV -S200 NEEDS TO BE SENT INTO THE NATIONAL SERVICE CENTER FOR EVALUATION AND REPAIR. ADDITIONALLY, THE CUSTOMER WAS ASKED CONTACT FOR THE SERIAL AND MODEL NUMBERS FOR THE CAMERA HEADS THAT HE WAS TRYING TO USE, HE DID NOT HAVE THEM AVAILABLE AND COULD NOT PROVIDE AT TIME OF CALL. THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE CORRECTION OF THE INITIAL MDR 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. IT HAS BEEN OVER ONE (1) YEAR, SINCE THE SUBJECT DEVICE WAS MANUFACTURED. A DEFINITIVE ROOT CAUSE WAS NOT IDENTIFIED. HOWEVER, BASED ON THE RESULTS OF THE INVESTIGATION, THE PROBABLE CAUSE OF THE "ERROR E226 ENDOSCOPE COMMUNICATION ERROR" MALFUNCTION COULD NOT BE IDENTIFIED. THREE ATTEMPTS WERE MADE TO OBTAIN, ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT, BUT NO RESPONSE WAS RECEIVED FROM THE CUSTOMER. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE VIDEO SYSTEM CENTER EXHIBITED ERROR E226(SCOPE COMMUNICATION ERROR). THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123060 VISERA ELITE II VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET SHIRAKAWA OLYMPUS CO., LTD. OTV-S200 04953170386022

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown