BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 13217295 · Received January 11, 2022

    Report

    Report Number
    8010047-2022-01181
    Event Type
    Malfunction
    Date Received
    January 11, 2022
    Report Date
    May 3, 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
    HI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC) SUPPORT SPOKE TO THE CUSTOMER TO TROUBLESHOOT THE DEVICE. THE CUSTOMER SUSPECTED THE RED, GREEN, BLUE (RGB) CABLE TO BE THE CAUSE OF NO IMAGE SINCE IT WAS DAMAGED. THE CUSTOMER WAS ABLE TO OBTAIN IMAGES AFTER REPLACING THE RBG HOWEVER, NO IMAGE ISSUE PERSISTED WITH THE 160 SERIES SCOPE. IN ADDITION, THERE WAS A PRINTER COMMUNICATION OR SIGNAL PROBLEM. THE CUSTOMER WAS NOT IN FRONT OF THE DEVICE AT THE TIME OF CALL AND OPTED TO CALL LATER. THE CUSTOMER CALLED BACK AND TAC CONFIRMED THAT SCOPE IMAGE WAS RECEIVED WHEN USING THE GIF-HQ190. THE CUSTOMER WAS UNABLE TO PRINT REMOTE SCOPE IMAGES TAKEN WITH THE CV-190 OUT ON THE OEP-5 PRINTER. TAC CONFIRMED THAT THE CUSTOMER WAS ABLE TO TAKE IMAGES WHEN PRESSING THE CAPTURE BUTTON ON THE FRONT PANEL OF THE PRINTER. TAC ALSO CONFIRMED THAT THE CUSTOMER HAD AN RS-232C CABLE CONNECTED FROM THE OEP-5 PRINTER TO THE MAJ-1916 INTERFACE BOX. THE CUSTOMER DID NOT HAVE ANY OTHER CABLES CONNECTED TO THE MAJ-1916 INTERFACE BOX. TAC ADVISED THE CUSTOMER THAT AN MAJ-1918 CABLE WAS NEEDED TO CONNECT FROM THE CV PORT OF THE MAJ- 1916 TO THE ADAPTER PORT OF THE CV-190. THE CUSTOMER CONNECTED THE SAME 160 SERIES SCOPE AND MAJ-1430 VIDEO CABLE TO A DIFFERENT CV-190 TOWER AND RECEIVED IMAGE. TAC TRANSFERRED THE CALL TO THE NATIONAL SERVICE CENTER TO SEND IN THE DEVICE FOR REPAIR. A FOLLOW UP WAS MADE AND THE CUSTOMER WAS UNSURE IF THE DEVICE WILL BE SENT IT. THE DEVICE HAS NOT BEEN RECEIVED TO DATE. THE INVESTIGATION IS ONGOING; THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME, HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S DEVICE EVALUATION AND INVESTIGATION. BASED ON THE RESULTS OF THE DEVICE EVALUATION, A NON-REPORTABLE PHENOMENON SUCH AS A CORRODED REAR PANEL WAS IDENTIFIED. THE REPORTED EVENT OF NO IMAGE BEING DISPLAYED WAS DUPLICATED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 9 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE LEGAL MANUFACTURER'S INVESTIGATION, THE ROOT CAUSE OF NO IMAGE APPEARING WITH THE 160 SCOPE COULD NOT BE IDENTIFIED. HOWEVER, IT IS LIKELY THE CAUSE IS RELATED TO A FAULTY PATIENT BOARD SET/DEFECT ASSOCIATED WITH THE OPERATIONAL AMPLIFIER CIRCUIT DESIGN CHANGE OF THE PRINTED CIRCUIT BOARD (DR BOARD). THE CIRCUIT DESIGN OF THE OPERATIONAL AMPLIFIER OF THE DR BOARD WAS CHANGED BECAUSE IT DID NOT MEET THE SPECIFICATIONS. THE DR BOARD DESIGN CHANGE WAS CONFIRMED TO HAVE BEEN MADE ON APRIL 16, 2018. THIS ALSO CONFIRMS THAT THE REPORTED DEVICE WAS MANUFACTURED PRIOR TO THE DESIGN CHANGE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE EVIS EXERA III VIDEO SYSTEM CENTER DISPLAY IMAGE. THE EVENT OCCURRED DURING PREPARATION FOR USE. THERE WAS NO PATIENT INVOLVEMENT, NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181346 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 GIF-HQ190| MAJ-1430 MAJ- 1916