BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO SYSTEM CENTER

    MDR report key: 10293142 · Received July 18, 2020

    Report

    Report Number
    8010047-2020-04556
    Event Type
    Malfunction
    Date Received
    July 18, 2020
    Date of Event
    June 23, 2020
    Report Date
    January 14, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K122831
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OMSC BUT WAS RETURNED TO OLYMPUS VIETNAM (OVN). IN THE EVALUATION OF OVN CHECKED THE SUBJECT DEVICE AND FOUND THE FOLLOWING. THE ELECTRICAL CONTACT OF THE VIDEO CONNECTOR SOCKET WAS CORRODED AND DEFORMED. OVN SURMISED THAT THE REPORTED PHENOMENON WAS ATTRIBUTED TO THE CORROSION AND/OR DEFORMATION OF THE ELECTRICAL CONTACT OF THE VIDEO CONNECTOR SOCKET DUE TO THE FLUID INVASION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER¿S FINAL INVESTIGATION. THE FOLLOWING SECTIONS WERE UPDATED: A1, D4, D10, G4, G7, H2, H3, H4, H6, AND H10. THE DEVICE WAS RETURNED TO AN OLYMPUS SERVICE CENTER FOR EVALUATION AND REPAIR. THE TECHNICIAN CONFIRMED . --B30 ERROR (RUST AND DEFORMATION OF THE VIDEO SOCKET PIN). --A LOOSE ENDOSCOPE SOCKET (WEAR OF THE SOCKET). --THE LAMP ON/OFF SWITCH MAY NOT WORK. (FRONT PANEL UNIT FAILURE). IT IS PRESUMED THAT ELECTRICAL CONTACT FAILURE OCCURRED BY THE USER CONNECTING THE VIDEO CONNECTOR TO THE SUBJECT PRODUCT WITHOUT SUFFICIENTLY DRYING THE ELECTRICAL CONTACTS OF THE VIDEO CONNECTOR, OR BY THE USER CLEANING THE VIDEO CONNECTOR SOCKET, CAUSING THE PHENOMENON. BY THIS, IT IS ALSO PRESUMED THAT A STABLE COMMUNICATION BETWEEN THE ENDOSCOPE AND THE VIDEO PROCESSOR BECOMES IMPOSSIBLE AND B30 ERROR OCCURRED. ABOUT 5 YEARS HAVE PASSED SINCE THE SUBJECT PRODUCT WAS MANUFACTURED, AND IT IS PRESUMED THAT WEAR OF THE SOCKET OCCURRED BY FREQUENTLY AND REPEATEDLY INSTALLING AND REMOVING THE ENDOSCOPE. IT IS PRESUMED THAT THE FRONT PANEL FAILED BECAUSE A LARGE LOAD (E.G. A HARD OBJECT ACCIDENTALLY HIT) DEVIATING FROM THE RECOMMENDED SERVICE CONDITIONS WAS MOMENTARILY APPLIED FROM THE OUTSIDE, OR DUE TO AN ACCIDENTAL FAILURE OF THE PARTS. BASED ON THE LEGAL MANUFACTURER¿S INVESTIGATION, THE DHR WAS REVIEWED AND THERE WERE NO PROBLEMS FOUND DURING THE MANUFACTURING OF THE DEVICE. THE DEVICE MET ALL SPECIFICATIONS AT THE TIME OF SHIPMENT. THE FOLLOWING IS DESCRIBED IN THE INSTRUCTION MANUAL OF CV-170: --BEFORE CONNECTING THE VIDEO CONNECTOR TO THE VIDEO SYSTEM CENTER, CONFIRM THAT THE VIDEO CONNECTOR, INCLUDING THE ELECTRICAL CONTACTS, IS COMPLETELY DRY AND FOREIGN OBJECTS SUCH AS DETERGENT REMNANTS, HARD WATER RESIDUE, FINGER GREASE, DUST, AND LINT ARE NOT ON THE ELECTRICAL CONTACTS. IF THE ENDOSCOPE IS USED WITH WET AND/OR DIRTY ELECTRICAL CONTACTS, THE ENDOSCOPE AND VIDEO SYSTEM CENTER MAY MALFUNCTION. REGARDING THE PROHIBITION ON CLEANING OF THE CONNECTOR CONTACTS, THE FOLLOWING IS DESCRIBED IN THE INSTRUCTION MANUAL. --DO NOT CLEAN THE VIDEOSCOPE CABLE CONNECTOR SOCKET, THE TERMINALS, AND THE AC MAINS POWER INLET. CLEANING THEM CAN DEFORM OR CORRODE THE CONTACTS, WHICH COULD DAMAGE THE VIDEO SYSTEM CENTER.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IN THIS REPORT HAS NOT BEEN RETURNED TO OMSC FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING A PREPARATION FOR AN UNSPECIFIED PROCEDURE USING THE SUBJECT DEVICE AT THE USER FACILITY, THE SCOPE COMMUNICATION ERROR B30 WAS DISPLAYED ON THE MONITOR. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT. THE USER FACILITY DID NOT PROVIDE OTHER DETAILED INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757395 VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET OLYMPUS MEDICAL SYSTEMS CORP. CV-170

    Patients

    Seq Age Sex Outcome Treatment
    1