BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 13165857 · Received January 5, 2022

    Report

    Report Number
    8010047-2022-00879
    Event Type
    Malfunction
    Date Received
    January 5, 2022
    Date of Event
    December 9, 2021
    Report Date
    February 2, 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
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC) SUPPORT SPOKE TO THE CUSTOMER TO TROUBLESHOOT THE DEVICE. TAC CHECKED THE SCOPE SWITCH SETTING AND THE PUMP WAS NOT ASSIGNED TO ANY SWITCH BUT TAC ASSISTED THE CUSTOMER TO SET THE SCOPE SWITCH TO PUMP. THE CUSTOMER SAW AN E209 INTERNAL BUFFER ERROR AFTER PRESSING A BUTTON HOWEVER, THE ERROR DISAPPEARED AFTER THE DEVICE WAS POWER RECYCLED. AFTERWARDS, THE OFP-2 PUMP WAS IRRIGATING AND THE OEP-5 PRINTER CAPTURED UPON DEMAND WITH NO FURTHER PROBLEM AFTER PROPER SWITCH ASSIGNMENT FROM THE CV-190. THE ISSUE WAS RESOLVED AND NO DEVICE WILL BE SENT IN FOR REPAIR AND EVALUATION. 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 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 6 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, REGARDING THE EVIS EXERA III VIDEO SYSTEM CENTER WOULD NOT ACTIVATE OFP-2 PUMP, IT WAS DETERMINED THERE WAS IMPROPER SWITCH ASSIGNMENT. ONCE THE SWITCH WAS ALIGNED CORRECTLY THE ISSUE WAS NO LONGER PRESENT. 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 DOES NOT ACTIVATE THE OFP-2 PUMP. 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
    1453892 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