BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO ADAPTER

    MDR report key: 18460969 · Received January 5, 2024

    Report

    Report Number
    3002808148-2024-30056
    Event Type
    Malfunction
    Date Received
    January 5, 2024
    Date of Event
    December 6, 2023
    Report Date
    March 1, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    GCJ
    UDI-DI
    04953170023804
    PMA / PMN Number
    K955404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED FOR CORRECTION TO THE DEVICE MODEL NUMBER. PLEASE SEE UPDATES TO THE FOLLOWING FIELDS: D4 (MODEL NUMBER, UDI), H2, H4 AND H10. THIS REPORT CAPTURES THE COMPLAINT ON VIDEO ADAPTER. THE RELATED CAMERA HEAD COMPLAINT IS CAPTURED IN PATIENT IDENTIFIER: (B)(6) (REPORT REF #: 3002808148-2023-20019-00).

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 0

    THE MDR SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE FINAL INVESTIGATION RESULTS AND ADDITIONAL INFORMATION. THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE CUSTOMER'S ALLEGATION WAS CONFIRMED. POOR CABLE CONTACT (INDICATED BY THE USER WAS REPRODUCED BY THE REPAIR DEPARTMENT. THE CAUSE HAS ALREADY BEEN ISOLATED AS THE OCCURRENCE OF HORIZONTAL STRIPES IN THE IMAGE DUE TO A TWISTED CABLE IN THE COMBINATION DEVICE. IN ADDITION, A NEW APPEARANCE ABNORMALITY WAS OBSERVED. THE HEAD AND ADAPTER ARE CORRODED AND CANNOT BE DISASSEMBLED. A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED. A DEVICE HISTORY REVIEW CANNOT BE PERFORMED DUE TO LACK OF LOT/SERIAL NO. INFORMATION. THE INSTRUCTION MANUAL FOR THE DEVICE IN QUESTION WAS CHECKED. AS A RESULT, NO ABNORMALITY WAS FOUND. -ARE THE REPORTED RISK OR HARMS DOCUMENTED IN THE IFU? ¿WARNING/CAUTION IS STATED. (REFER TO THE RELEVANT SECTION OF THE IFU) -WAS THE DEVICE USED ACCORDING TO THE IFU AND THE LABEL? IT COULD NOT BE DETERMINED FROM THE COMPLAINT INFORMATION WHETHER IT WAS USED IN ACCORDANCE WITH THE IFU. -DOES THE IFU/LABEL NEED TO BE REVISED OR IS THERE A PROBLEM WITH THE TRANSLATIONS, DESCRIPTIONS, OR FIGURES? ¿NO NEED TO BE REVISED. SECTION WHERE IFU APPLICABLE] OPERATION (WARNING) IF AN ABNORMAL ENDOSCOPIC IMAGE/FUNCTION OCCURS AND RETURNS TO ITS NORMAL CONDITION BY ITSELF, THE EQUIPMENT HAS MALFUNCTIONED. CONTINUED USE IN SUCH CONDITION MAY CAUSE ABNORMALITY AGAIN AND IT MAY NOT BE ABLE TO RECOVER TO NORMAL CONDITION. IN THIS CASE, IMMEDIATELY STOP USE AND WITHDRAW THE ENDOSCOPE FROM THE PATIENT SLOWLY. CONTINUED USE OF SUCH EQUIPMENT MAY CAUSE PATIENT INJURY, BLEEDING AND/OR PERFORATION. IF THE ENDOSCOPIC IMAGE ON THE VIDEO MONITOR SHOULD UNEXPECTEDLY DISAPPEAR OR FREEZE DURING AN EXAMINATION AND CANNOT BE RESTORED, TURN OFF AND THEN ON AGAIN. IF THE IMAGE STILL DOES NOT APPEAR, IMMEDIATELY TURN OFF. DISCONNECT THE CAMERA HEAD FROM THE ENDOSCOPE AND CAREFULLY WITHDRAW THE ENDOSCOPE FROM THE PATIENT, WHILE VIEWING THROUGH THE ENDOSCOPE¿S EYEPIECE. IN ADDITION, BE SURE TO PREPARE ANOTHER CAMERA HEAD TO ENSURE THAT THE EXAMINATION DOES NOT NEED TO BE INTERRUPTED DUE TO EQUIPMENT FAILURE OR MALFUNCTION. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE CAMERA HEAD LEADS HAD POOR CONTACT, THE CABLE OF CAMERA HEAD IS TWISTED AND DISTORTED, RESULTING IN HORIZONTAL STRIPES IN THE IMAGE, CAMERA HEAD AND ADAPTER ARE CORRODED AND CANNOT BE DISASSEMBLED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569348 VIDEO ADAPTER VIDEO ADAPTER GCJ SHIRAKAWA OLYMPUS CO., LTD. AR-T12E 04953170023804

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown