BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA ELITE VIDEO SYSTEM CENTER

    MDR report key: 7875833 · Received September 14, 2018

    Report

    Report Number
    8010047-2018-01779
    Event Type
    Malfunction
    Date Received
    September 14, 2018
    Date of Event
    September 1, 2018
    Report Date
    March 7, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K954451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT OTV-S190 WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC). OMSC EVALUATED THE SUBJECT OTV-S190 AND FOUND THAT THE POWER SUPPLY WAS NOT WORKED. OMSC FOUND THAT THERE WAS A LOT OF DUST AROUND A COOLING FAN OF THE POWER SUPPLY UNIT AND A STAIN AT THE TOP COVER AROUND THE POWER SUPPLY UNIT. OMSC ASSEMBLED THE POWER SUPPLY UNIT IN THE SUBJECT OTV-S190 INTO OMSC ASSET OTV-S190, AND CONFIRMED THE OPERATION. AS A RESULT, OMSC FOUND OMSC ASSET OTV-S190 WAS NOT WORKED. IN ADDITION, OMSC ASSEMBLED THE POWER SUPPLY UNIT IN THE OMSC ASSET OTV-S190 INTO THE SUBJECT OTV-S190, AND CONFIRMED THE OPERATION. AS A RESULT, OMSC FOUND THE SUBJECT OTV-S190 COULD BE WORKED. BASED ON ABOVE EVALUATION RESULT, OMSC IDENTIFIED THAT THE FAILURE WAS ATTRIBUTED TO THE POWER SUPPLY UNIT OF THE SUBJECT OTV-S190. OMSC ASKED POWER SUPPLY UNIT MANUFACTURER TO INVESTIGATE THE POWER SUPPLY UNIT OF THE SUBJECT OTV-S190 TO IDENTIFY ROOT CAUSE. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) SENT THE POWER SUPPLY UNIT OF THE SUBJECT OTV-S190 TO THE POWER SUPPLY UNIT MANUFACTURER TO IDENTIFY ROOT CAUSE. AS A RESULT, THE POWER SUPPLY UNIT MANUFACTURER FOUND THAT SEVERAL ELECTRONIC COMPONENTS ON THE CIRCUIT BOARD IN THE POWER SUPPLY UNIT WAS BURNOUT AND HAD DAMAGE. WHEN REPLACING ALL DAMAGED ELECTRONIC COMPONENTS WITH NEW ELECTRONIC COMPONENTS, THE POWER SUPPLY UNIT OPERATED NORMALLY. THEREFORE, IT WAS CONCLUDED THE FAILURE PHENOMENON, WHICH THE POWER SUPPLY OF THE SUBJECT OTV-S190 DID NOT WORK, WAS CAUSED BY BREAKAGE OF THE ELECTRONIC COMPONENTS. IN ADDITION, THE POWER SUPPLY UNIT MANUFACTURER FOUND THAT A LOT OF DUST ADHERED TO AROUND DAMAGED ELECTRONIC COMPONENTS AND THE FAN OF THE POWER SUPPLY UNIT. BASED ON AN INVESTIGATION RESULT SO FAR, OMSC SURMISED THERE IS A POSSIBILITY IN THEORY THAT THE CIRCUIT WAS UNINTENTIONALLY SHORTED ELECTRICALLY BY THE DUST, AND ELECTRONIC COMPONENTS WERE DAMAGED AND BURNED OUT. THE OTV-S190 INSTRUCTION MANUAL STATES THE CLEANING AND MAINTENANCE PROCEDURE FOR THE DEVICE. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT OTV-S190 HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) YET. OMSC WILL INVESTIGATE THE SUBJECT OTV-S190 TO IDENTIFY THE ROOT CAUSE OF THIS FAILURE PHENOMENON WHEN OMSC RECEIVES IT. THE OTV-S190 INSTRUCTION MANUAL STATES THE CORRESPONDING METHOD WHEN THERE IS AN ABNORMALITY FOR THE DEVICE. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    DURING AN UNSPECIFIED DIAGNOSIS, ABNORMAL NOISE OCCURRED AND SMOKE CAME FROM THE SUBJECT OTV-S190. THE USER REPLACED THE SUBJECT OTV-S190 WITH AN UNSPECIFIED PRODUCT, AND COMPLETED THE DIAGNOSIS. THERE WAS NO REPORT OF THE PATIENT¿S AND THE USER'S INJURY REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716701 VISERA ELITE VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET OLYMPUS MEDICAL SYSTEMS CORP. OTV-S190

    Patients

    Seq Age Sex Outcome Treatment
    1