BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPE POSITION DETECTING UNIT

    MDR report key: 17090993 · Received June 8, 2023

    Report

    Report Number
    3002808148-2023-05751
    Event Type
    Malfunction
    Date Received
    June 8, 2023
    Date of Event
    January 19, 2023
    Report Date
    July 25, 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
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER. THE E1 "TELEPHONE NUMBER" WAS CORRECTED DUE TO INCORRECT COUNTRY CODE FORMAT. THE G2 FIELD WAS CORRECTED BASED ON THE INFORMATION AVAILABLE AT THE TIME OF THE INITIAL SUBMISSION. THE CUSTOMER CONFIRMED THERE HAVE BEEN NO REPORTS OF PATIENT USE OR HEALTH HAZARDS SINCE THE INCIDENT. THE COMPANY CONTINUES TO RECOGNIZE THAT THE USE OF THE PRODUCT IN PACEMAKER PATIENTS IS CONTRAINDICATED. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE SERIAL NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA.

    Additional Manufacturer Narrative · 0

    THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORT BASED ON ENHANCEMENTS MADE TO THE COMPANY¿S MDR AND COMPLAINT HANDLING PROCESSES. CAPAS HAVE BEEN OPENED TO MANAGE THE ACTIONS THAT ARE BEING TAKEN TO REMEDIATE THIS ISSUE AND ENSURE ANY REQUIRED MDR REPORTING IS COMPLETED. THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT THE EVENT WAS CAUSED BY MISUSE DUE TO MISPERCEPTION BY A PHYSICIAN. DESCRIPTIONS OF THE INDICATED PHENOMENA WERE AMBIGUOUS, AND BECAUSE NO RESPONSE FROM THE INSTITUTION WAS OBTAINED ABOUT THIS PHENOMENON, THE CAUSE AND THE INDICATED PHENOMENON WERE NOT IDENTIFIED. A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THAT THE DEVICE MAY HAVE BEEN USED ON A PATIENT WITH A PACEMAKER. AT THAT TIME, THE DOCTOR RECOGNIZED THAT ITS USE WAS CONTRAINDICATED. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1057151 ENDOSCOPE POSITION DETECTING UNIT ENDOSCOPE POSITION DETECTING UNIT PGU SHIRAKAWA OLYMPUS CO., LTD. UPD-3 04953170331145

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown