BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRA

    MDR report key: 20366794 · Received October 4, 2024

    Report

    Report Number
    9610877-2024-00129
    Event Type
    Malfunction
    Date Received
    October 4, 2024
    Date of Event
    September 20, 2024
    Report Date
    December 3, 2024
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    UDI-DI
    04961333251896
    PMA / PMN Number
    K231249
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION INFORMATION: B4: DATE OF THIS REPORT, G6: TYPE OF REPORT, H2: IF FOLLOW-UP, WHAT TYPE?, H3: DEVICE EVALUATED BY MANUFACTURE AND H6: CODING CHANGED BASED ON THE INVESTIGATION RESULT. EVALUATION SUMMARY: BASED ON THE INVESTIGATION, A POTENTIAL ROOT CAUSE OF THIS FAILURE IS PHYSICAL CONNECTION FAILURE IN THE GLOBAL CONNECTOR. A DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE IDENTIFIED. PENTAX MEDICAL HAS NOT RECEIVED ANY FURTHER INFORMATION FOR THIS EVENT AND THEREFORE, CONSIDERS THIS MEDWATCH REPORT CLOSED. 9610877-2024-00128_EG29-I20C_(B)(6)_ ERROR MESSAGE 04-0004 CHECK ENDOSCOPE CONNECTION. 9610877-2024-00129_EC38-I20CL_(B)(6)_ERROR MESSAGE 04-0004 CHECK ENDOSCOPE CONNECTION.

    Additional Manufacturer Narrative · 0

    THE PENTAX MEDICAL AMERICA MADE A GOOD FAITH EFFORT VIA EMAIL ON 23-SEP-2024 AND RECEIVED THE FOLLOWING INFORMATION. WAS EACH PROCEDURE FOR TREATMENT OR DIAGNOSTIC PURPOSES? DIAGNOSTIC. WERE THE PRODUCTS IN QUESTION USED TO COMPLETE EACH PROCEDURE? YES WAS EACH PATIENT RECALLED FOR FURTHER SCREENING? YES IF YES, WHEN AND WHAT WERE THEIR RESULTS(DD/MM/YYYY)? HASN'T HAPPENED YET IF NO, WILL EACH PATIENT BE RECALLED FOR FURTHER SCREENING? YES WHAT IS THE CURRENT STATUS OF EACH PATIENT? FINE COULDN'T GET PICTURE WERE THE PRODUCTS IN QUESTION REMOVED FROM CIRCULATION IMMEDIATELY AFTER THE FAILURE/EVENT OCCURRED AND SUBSEQUENTLY CALLED IN FOR SERVICE/REPLACEMENT? YES CURRENT LOCATION AND STATUS OF THE PRODUCTS IN QUESTION? BEING SENT BACK FOR REVIEW. THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED PENTAX MEDICAL MIYAGI ON 13-JUN-2024 UNDER NORMAL CONDITIONS, PASSED ALL REQUIRED INSPECTIONS AND WAS RELEASED ACCORDINGLY. ALSO, THERE WERE NO REWORKS OR CONCESSIONS AND THE DATES OF APPROVAL FOR SHIPMENT AND ACTUAL DATE SHIPPED WERE CONFIRMED ON 19-JUN-2024. INVESTIGATION IS IN-PROCESS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THE FOLLOWING ERROR MESSAGE: 04-0004 CHECK ENDOSCOPE CONNECTION. ONCE THIS HAPPENS, THEY CAN'T TAKE PICTURES DURING PROCEDURE. DESCRIPTION OF ANY ACTIONS TAKEN: TOOK SCOPE OUT AND THEN PLACED IT BACK IN. SAME RESULT. THIS EVENT OCCURRED AT THE TIME OF DURING USE. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693577 INSPIRA PENTAX MEDICAL VIDEO COLONOSCOPE EC38-I20C SERIES FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC38-I20CL 04961333251896

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown