BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 7845191 · Received September 5, 2018

    Report

    Report Number
    8010047-2018-01712
    Event Type
    Malfunction
    Date Received
    September 5, 2018
    Date of Event
    August 16, 2018
    Report Date
    March 25, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K102379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A SUPPLEMENTAL REPORT FOR MFR REPORT #8010047-2018-01712. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) COULD NOT INVESTIGATE THE SUBJECT OEV262H, BECAUSE THE SUBJECT OEV262H IS NOT RETURNED TO OMSC. SINCE OMSC COULD NOT INVESTIGATE THE SUBJECT DEVICE, THE EXACT CAUSE HAS BEEN UNKNOWN; HOWEVER, THE FOLLOWING ARE SUPPOSED TO BE THE CAUSE. THE APPEARED IMAGE ON SUBJECT DEVICE BLACKED OUT BY THE HIGH FREQUENCY NOISE OF THE ELECTROSURGICAL UNIT, BECAUSE THE SUBJECT DEVICE WAS PLACED NEXT TO THE ELECTROSURGICAL UNIT. THE INSTRUCTION MANUAL OF THE OEV262H STATES THE CORRESPONDING METHOD IN CASE OF AN ABNORMALITY.

    Additional Manufacturer Narrative · 1

    THE SUBJECT OEV262H WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) CHECKED THE DEVICE HISTORY RECORD OF THE SUBJECT DEVICE; THERE WAS NO IRREGULARITY FOUND. 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 ELECTROSURGERY PROCEDURE USING TWO OR MORE UNSPECIFIED MONITORS, THE IMAGE ON THE MONITOR OEV262H, WHICH WAS PLACED IN FRONT OF THE USER, BLACKED OUT. THE USER MOVED THE PATIENT TO ANOTHER ENDOSCOPY ROOM AND COMPLETED THE PROCEDURE. THE USER FACILITY REPORTED THAT THIS PHENOMENON OCCURRED IN BOTH CASES OF THE ELECTROSURGICAL UNIT: ESG-100 AND AN UNSPECIFIED ELECTROSURGICAL UNIT MADE BY ERBE (B)(4), AND ALSO OCCURRED EVEN WHEN THEY CHANGED THE POWER OUTLET OF THE SUBJECT OEV262H AND THE POWER OUTLET OF THE ELECTROSURGICAL UNIT FOR SEPARATE ONES. FURTHER, THE USER FACILITY REPORTED THAT THEY SET UP THE ISOLATION TRANSFORMER: MB631 FOR THE SUBJECT OEV262H, AND ALSO CONDUCTED POTENTIAL EQUALIZATION BETWEEN THE SUBJECT OEV262H AND THE ELECTROSURGICAL UNIT. HOWEVER, THE PHENOMENON DID NOT IMPROVE. THE USER FACILITY PRESUMED THAT THIS PHENOMENON OCCURRED BECAUSE THE SUBJECT OEV262H WAS PLACED NEXT TO THE ELECTROSURGICAL UNIT. THERE WAS NO PATIENT INJURY REPORTED OTHER THAN BEING MOVED TO ANOTHER ENDOSCOPY ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687288 HIGH DEFINITION LCD MONITOR HIGH DEFINITION LCD MONITOR FET OLYMPUS MEDICAL SYSTEMS CORP. OEV262H

    Patients

    Seq Age Sex Outcome Treatment
    1