BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA ELITE VIDEO SYSTEM CENTER

    MDR report key: 11843516 · Received May 18, 2021

    Report

    Report Number
    8010047-2021-06461
    Event Type
    Malfunction
    Date Received
    May 18, 2021
    Date of Event
    April 27, 2021
    Report Date
    June 8, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    UDI-DI
    04953170301964
    PMA / PMN Number
    K111425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE LM INVESTIGATION. PLEASE SEE THE UPDATES IN SECTIONS: G4, G7, H2, H3, H4, H6 AND H10. THE LEGAL MANUFACTURER (LM) REVIEWED THE CONTENT OF THIS COMPLAINT FOR FURTHER INVESTIGATION. THE LM REPORTS THAT THE ROOT CAUSE COULD NOT BE IDENTIFIED. THE UNIT WAS DELIVERED TO THE CUSTOMER ON DECEMBER 28, 2012. THE LEGAL MANUFACTURER PROVIDED THE FOLLOWING POSSIBLE CAUSE FOR THE REPORTED EVENT ARE PRESUMED AS FOLLOWS: THE BENT PORT WAS ATTRIBUTED TO SCOPE AND IT OCCURRED THE FOLLOWING SEQUENCES. ·CHIPPED OR FOREIGN OBJECT AROUND PORT WERE HOOKED ON TO THE SOCKET IN THE VIDEO CONNECTOR OF CV-170 WHEN CONNECTING TO THE CONNECTOR SOCKET. ·HOOKED VIDEO CONNECTOR WAS INSERTED FURTHER, PORTS IN THE VIDEO CONNECTOR SOCKET WERE PUSHED AND BENT. A DESCRIPTION WAS FOUND IN OTV-S190 INSTRUCTION MANUAL. FOLLOWING THIS COULD HAVE PREVENTED THE PHENOMENON TO OCCUR. IMPORTANT INFORMATION ¿ PLEASE READ BEFORE USE DO NOT APPLY EXCESSIVE FORCE TO THIS VIDEO SYSTEM CENTER AND/OR OTHER INSTRUMENTS CONNECTED. OTHERWISE, DAMAGE AND/OR MALFUNCTION CAN OCCUR. 6.3 CONNECTION OF AN ENDOSCOPE ·CONFIRM THAT THE ELECTRICAL CONTACTS INSIDE THE VIDEO CONNECTOR SOCKET OF THIS INSTRUMENT ARE NOT DAMAGED. ·CONFIRM THAT THE VIDEO CONNECTOR OF THE VIDEO SCOPE / CAMERA HEAD ARE NOT DAMAGED. AS A RESULT OF THE DHR REVIEW, IT WAS CONFIRMED THAT THERE WAS NO ABNORMALITY IN MANUFACTURING, CONCESSION, AND VARIATION.

    Additional Manufacturer Narrative · 1

    AS PART OF OUR INVESTIGATION, THE TECHNICAL ASSISTANCE CENTER (TAC) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING. THE CUSTOMER TRIED OTHER CYF-V2 SCOPES WITH THE SAME RESULT. TAC RESEARCHED THE SETTING FOR PVP LASER AND CALLED THE CUSTOMER BACK. THE CUSTOMER WAS ABLE TO PERFORM SOME TROUBLESHOOTING. TAC INSTRUCTED THE CUSTOMER TO SELECT THE USER SETTING FOR THE VIDEO SCOPE WHILE CONNECTED TO THE OTV-S190. THE CUSTOMER STILL DID NOT HAVE A VIDEO IMAGE. THE CUSTOMER REPORTED THAT THEY WERE USING THE SERIAL DIGITAL INTERFACE (SDI) OUT, FROM THE OTV-S190 TO THE OEV-261H MONITOR. THE CUSTOMER REPORTED THAT THE MONITOR DISPLAYED A HD 15 VIDEO SIGNAL. TAC REQUESTED THAT THE CUSTOMER SET PORT A TO SDI AND THERE WAS NO IMAGE OBSERVED. AT THAT TIME AN OLYMPUS REPRESENTATIVE ARRIVED ONSITE TO PERFORM TROUBLESHOOTING. ON APRIL 29, 2021, A FOLLOW UP CALL WAS MADE AND THE CUSTOMER STATED THAT THE OTV-S190 WOULD BE SENT IN FOR INSPECTION. THE UNIT WAS RETURNED TO THE SERVICE CENTER FOR EVALUATION. THE CUSTOMER¿S COMPLAINT OF ¿NOT WORKING WITH THE CYF-V2¿ WAS CONFIRMED. THE UNIT DOES WORKS WITH OTHER. IN ADDITION, BENT PINS WERE FOUND INSIDE THE VIDEO CONNECTOR CAUSING ROLLING IMAGE WITH LTF-VH SCOPE. THE UNIT WAS EQUIPPED WITH AN UP TO DATE MAIN SWITCH AND SOFTWARE VER. 3.10.

    Description of Event or Problem · 1

    THE SERVICE CENTER WAS INFORMED THAT DURING PREPARATION FOR USE, NO IMAGE WAS OBSERVED ON THE VIDEO SYSTEM WHEN USING THE CYSTOSCOPE. THE CUSTOMER REPORTED THAT A ¿LASER PVP ONLY BOX¿ APPEARED ON THE SCREEN MOMENTARILY. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739256 VISERA ELITE VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET OLYMPUS MEDICAL SYSTEMS CORP. OTV-S190 04953170301964

    Patients

    Seq Age Sex Outcome Treatment
    1