BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 11230781 · Received January 26, 2021

    Report

    Report Number
    8010047-2021-01894
    Event Type
    Malfunction
    Date Received
    January 26, 2021
    Date of Event
    December 31, 2020
    Report Date
    March 12, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    UDI-DI
    04953170363498
    PMA / PMN Number
    K102379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE RESULTS OF THE LEGAL MANUFACTURER'S INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THOUGH THE DEVICE WAS NOT RETURNED, BASED ON THE LEGAL MANUFACTURER'S INVESTIGATION, IT IS LIKELY THE PHENOMENON WAS CAUSED BY THE EFFECTS OF HIGH-FREQUENCY NOISE BY THE USE OF AN ELECTROSURGICAL UNIT, AS A RESULT OF USER-HANDLING. A REVIEW OF THE INSTRUCTION MANUAL IDENTIFIES THE FOLLOWING VERBIAGE: HANDLING AND GENERAL PRECAUTIONS: "WHEN USING A RADIOFREQUENCY ABLATION POWER DEVICE WITH THIS PRODUCT, OUR RADIOFREQUENCY ABLATION POWER DEVICE SHOULD BE USED. USE OF A RADIOFREQUENCY ABLATION POWER DEVICE OTHER THAN OURS MAY CAUSE HIGH-FREQUENCY NOISE ON THE OBSERVATION MONITOR THAT AFFECTS THE OBSERVATION AND TREATMENT, OR THE OBSERVATION SCREEN MAY DISAPPEAR". IMPORTANT INFORMATION, PLEASE READ BEFORE USE: "BEFORE USING HIGH-FREQUENCY ELECTROSURGICAL EQUIPMENT, MAKE SURE THAT THE SIGNAL NOISE EMITTED FROM THE EQUIPMENT DOES NOT AFFECT THE OBSERVATION OF THE SURGICAL PROCEDURES. IF HIGH-FREQUENCY ELECTROSURGICAL EQUIPMENT IS USED WITHOUT SUCH CONFIRMATION, PATIENT INJURY MAY RESULT".

    Additional Manufacturer Narrative · 1

    AS PART OF OUR INVESTIGATION, THE TECHNICAL ASSISTANCE CENTER (TAC) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING. THE CUSTOMER REPORTED THAT THE SERIAL DIGITAL INTERFACE (SDI) INPUT SIGNAL WAS RUNNING THRU A BOOM. TAC SUGGESTED THAT THE CUSTOMER REROUTE ANOTHER SDI CABLE TO BYPASS THE BOOM AND SEE IF THERE IS A BROKEN OR COMPROMISED CABLE IN THE BOOM ALLOWING RF INTERFERENCE. THE CUSTOMER REPORTED THAT THE GENERATOR WAS NOT ON THE SAME CART AS THE VIDEO PROCESSOR AND WAS ACROSS THE ROOM. TAC ALSO, RECOMMENDED THAT THE CUSTOMER ENSURE THE GENERATOR WAS PLUGGED INTO A DIFFERENT BREAKER THAN THE VIDEO PROCESSOR. THE CUSTOMER PROVIDED TWO MODEL (27FT SDI CABLE, MAJ-1912.PLK) CABLES USED WITH THE UNIT. ON JANUARY 11, 2021 TAC PERFORMED A FOLLOW UP CALL TO THE CUSTOMER AND WAS INFORMED THAT THE MAJ-1912PLK WAS NOT TESTED FOR THE ERROR. AN ADDITIONAL, FOLLOW UP CALL WAS PERFORMED ON JANUARY 26, 2021 AND THE CUSTOMER REQUESTED THE SERVICE TICKET BE CLOSED AS A NEW CABLE WAS AVAILABLE FOR THE MONITOR. THE DEVICE WAS NOT RETURNED TO THE SERVICE CENTER FOR EVALUATION. THE INVESTIGATION IS ONGOING AND IF ADDITIONAL INFORMATION IS RECEIVED THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 1

    THE SERVICE CENTER WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, STATIC WAS OBSERVED ON THE MONITOR AND THEN THE IMAGE WOULD BE LOST WHEN THE ELECTROSURGICAL UNIT WAS USED. 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
    127229 HIGH DEFINITION LCD MONITOR HIGH DEFINITION LCD MONITOR FET OLYMPUS MEDICAL SYSTEMS CORP. OEV262H 04953170363498

    Patients

    Seq Age Sex Outcome Treatment
    1