BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPE POSITION DETECTING UNIT

    MDR report key: 15650453 · Received October 21, 2022

    Report

    Report Number
    3002808148-2022-03418
    Event Type
    Malfunction
    Date Received
    October 21, 2022
    Date of Event
    September 25, 2022
    Report Date
    February 14, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    PGU
    UDI-DI
    04953170331145
    PMA / PMN Number
    K134026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN 2 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, SINCE THE DEVICE WAS NOT RETURNED FOR AN EVALUATION, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. HOWEVER, IT IS LIKELY THAT THE FOLLOWING OCCURRED: PATIENT WAS LEFT IN PAIN DUE TO THE IMAGE ISSUE, AN ISSUE WITH THE PROCESSOR AND SCOPE GUIDE, AND/OR THERE WAS A CLINICALLY RELEVANT DELAY OCCURRED 45 MINUTES. THIS SUPPLEMENTAL REPORT INCLUDES A CORRECTION TO D4. UDI NUMBER INADVERTENTLY NOT INCLUDED ON THE INITIAL MEDWATCH. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING UPDATED TO REPORT CORRECTED INFORMATION.

    Additional Manufacturer Narrative · 0

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE DEFINITIVE CAUSE OF THE USER'S EXPERIENCE CANNOT BE DETERMINED AT THIS TIME. THE INVESTIGATION IS ONGOING. THIS REPORT WILL BE UPDATED UPON COMPLETION OF THE INVESTIGATION OR UPON RECEIPT OF ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS DURING AN UNSPECIFIED PROCEDURE USING AN ENDOSCOPIC POSITION DETECTING DEVICE WITH A VIDEO SYSTEM CENTER, THE USER WAS UNABLE TO CAPTURE AN IMAGE. THERE WAS A 45-MINUTE DELAY IN THE PROCEDURE WHICH LEFT THE PATIENT IN PAIN. THE USER HAD TO CAPTURE THE IMAGE MANUALLY. NO ADDITIONAL CONSEQUENCES TO THE PATIENT WERE REPORTED AS A RESULT OF THIS OCCURRENCE. THE EQUIPMENT WAS INSPECTED ONSITE BY MEDICAL ENGINEERING. MEDICAL ENGINEERING CONFIRMED THAT THE SCOPE GUIDE HAD A LOOSE CONNECTION WHICH WAS RESOLVED BY THE HOSPITAL¿S STAFF ON SITE. THE VIDEO SYSTEM CENTER HAD ISSUES WITH THE SETTINGS WHICH HAS NOW BEEN RECTIFIED USING TECH SUPPORT. WITH THAT SAID MEDICAL ENGINEERING BELIEVE THAT THE ISSUE DID NOT LIE WITH THE EQUIPMENT. THE EQUIPMENT IS NOT BEING RETURNED TO OLYMPUS FOR EVALUATION SINCE THE ISSUES WERE CORRECTED ONSITE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE VIDEO SYSTEM CENTER USED IN THE PROCEDURE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE ENDOSCOPIC POSITION DETECTING DEVICE USED IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2546309 ENDOSCOPE POSITION DETECTING UNIT ENDOSCOPE POSITION DETECTING UNIT PGU SHIRAKAWA OLYMPUS CO., LTD. UPD-3 04953170331145

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown