BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 14403326 · Received May 14, 2022

    Report

    Report Number
    8010047-2022-08263
    Event Type
    Malfunction
    Date Received
    May 14, 2022
    Date of Event
    April 14, 2022
    Report Date
    June 30, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    UDI-DI
    04953170298622
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IN SPEAKING WITH OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC), THE CUSTOMER REPORTED THE USER FACILITY IS WORKING ON AN INTEGRATION WITH THE ELECTRONIC HEALTH RECORD E CLINICAL WORKS (ECW). THE FACILITY HAS IMAGE CAPTURE CAPABILITIES BUT RAN INTO DIFFICULTY WITH THE INSTALL. THE WEEK PRIOR, AT THE BEGINNING OF THE INSTALL, IMAGES WERE ABLE TO BE SEEN ON THE BACK MONITOR WHERE THE PROGRAM RUNS BUT IMAGES CANNOT BE SEEN ON THE OLYMPUS MONITOR. ACCORDING TO THE CUSTOMER, THE SERIAL DEVICE INTERFACE (SDI) OUT 1 IS CONNECTED TO THE ENDOWORKS (EW) PERSONAL COMPUTER (PC) AND SDI OUT 2 TO THE ECW (EWC) PC AND THE CUSTOMER DID NOT WANT TO CHANGE THE CONFIGURATION. TAC FURTHER REVIEWED THE CABLING WITH THE CUSTOMER AND FOUND THE CUSTOMER USES THE MAJ-1918 REMOTE CABLE TO CONTROL VOLTAGE (CV) PORT ON MAJ-1916 CONVERTOR BOX, THE REMOTE CABLE FROM THE DF (FULL DUPLEX) PORT TO THE BLACK BOX TO THE PC. THE SDI IN CABLE ON THE OEV -261H MONITOR IS COMING FROM A BOX WITH PORT G THAT GOES TO EW. TAC INFORMED THE CUSTOMER THAT IF EW IS NOT CONNECTED TO THE CV-190 AND NOT ON, THERE WILL BE NO SIGNAL TO THE MONITOR, IT NEEDS A SIGNAL. TAC RECOMMENDED TO USE DIGITAL VISUAL INTERFACE (DVI) OUT OF CV-190 TO DVI IN ON THE OEV-261H. TAC INSTRUCTED THE CUSTOMER TO GO TO PERIPHERALS AND SET THE DIGITAL FILING SYSTEM TO OPTION AND OUTPUT TO SDI AND THEN GO INTO USER SETTINGS AND TURN PRINTER OFF AND DF DEVICE ON. ACCORDING TO THE CUSTOMER, ALL CABLING GOES THROUGH A BOOM AND THE CUSTOMER DOES NOT WANT TO RECONFIGURE. THE CUSTOMER DOES NOT PLAN ON RETURNING ANY EQUIPMENT TO OLYMPUS. THE CUSTOMER RECONNECTED EVERYTHING BACK UP TO EW AND IS ATTEMPTING TO WORK WITH ECW TO RESOLVE THE ISSUE. ADDITIONALLY, THE CUSTOMER MAY CONNECT TAC WITH THE TECHNICAL SUPPORT TEAM AT ECW FOR FURTHER ASSISTANCE IF NECESSARY. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND THE DEVICE HISTORY RECORD (DHR) REVIEW. A REVIEW OF DHR FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 7 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT THE FOLLOWING LED TO THE MALFUNCTION. THE OEV-261H'S SERIAL DIGITAL INTERFACE (SDI) IN WAS CONNECTED TO ENDO WORKS PC BOX, SUCH AS THE CONNECTION SYSTEM RELATED TO OEV-261H AND ENDO WORKS PC BOX. FURTHER INFORMATION WAS NOT AVAILABLE, THE ROOT CAUSE WAS NOT IDENTIFIED. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER CALLED OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC) REQUESTING ASSISTANCE WITH CONNECTING THE IMAGE MANAGEMENT SOFTWARE E CLINICAL WORKS TO THE EVIS EXERA III VIDEO SYSTEM CENTER AS THERE WAS NO IMAGE ON THE PRIMARY MONITOR OEV-261H. THE CUSTOMER NEEDED HELP WITH THE SETTINGS. THE EVENT DID NOT OCCUR DURING OR PRIOR TO A PROCEDURE AS THE SURGICAL CENTER WAS CLOSED TO WORK ON THIS ISSUE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT. RELATED PATIENT IDENTIFIERS: (B)(6) (OEV-261H) AND (B)(6) (CV-190).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039240 EVIS EXERA III VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET OLYMPUS MEDICAL SYSTEMS CORP. CV-190 04953170298622

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown OEV-261H.