BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 11098394 · Received December 30, 2020

    Report

    Report Number
    8010047-2020-11162
    Event Type
    Malfunction
    Date Received
    December 30, 2020
    Report Date
    March 8, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, THE PROBABLE CAUSE IS LIKELY THE PRODUCT WAS MANUFACTURED PRIOR TO A REDESIGN OF THE OP-AMP CIRCUIT OF THE PATIENT BOARD (DR BOARD), LEADING TO ONLY THE 180 SCOPE NOT DISPLAYED.

    Additional Manufacturer Narrative · 1

    THE UNIT WAS RETURNED TO THE SERVICE CENTER FOR EVALUATION. THE CUSTOMER¿S COMPLAINT OF ¿NO IMAGE WHEN USING PIGTAIL; TRIGGER NOT WORKING W/ PRINTER; POWER BUTTON STICKING¿ WAS PARTIALLY CONFIRMED. A FULL INSPECTION WAS PERFORMED AND FOUND A BLACK IMAGE WITH CONNECTED TO A THE TEST 180 SCOPE DUE TO FAULTY AP AND DR PATIENT BOARD SET. THE SCOPE SOCKET WAS FOUND WORN CAUSING A LOOSE CONNECTION WITH SCOPES AND CAMERA HEADS. THE UNIT WAS CHECKED WITH A TEST PRINTER OEP-5 AND FUNCTIONED NORMALLY AND THE POWER BUTTON WORKED; HOWEVER, IT SOMETIMES WAS STICKING DUE TO DIRT ON IT. THERE WAS COSMETIC WEAR NOTED ON THE UNIT¿S TOP COVER, FRONT PANEL AND FOOT THAT DOES NOT AFFECT FIT AND FUNCTIONALITY OF UNIT. THE UNIT WAS EQUIPPED WITH OUTDATED SOFTWARE AND OLD TYPE POWER SWITCH. THE UNIT WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE SERVICE CENTER WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE DISCOVERED AN ISSUE WITH THE UNIT¿S CONNECTOR CAUSING NO IMAGE TO APPEAR WHEN USING A PIGTAIL. IN ADDITION, THE USER REPORTED THAT THE TRIGGER DID NOT WORK WITH PRINTER AND THE POWER BUTTON ON THE UNIT WAS STICKING. IT IS UNKNOWN IF THE INTENDED PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1563229 EVIS EXERA III VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET OLYMPUS MEDICAL SYSTEMS CORP. CV-190

    Patients

    Seq Age Sex Outcome Treatment
    1