BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPE POSITION DETECTING UNIT

    MDR report key: 15735269 · Received November 4, 2022

    Report

    Report Number
    3002808148-2022-03841
    Event Type
    Malfunction
    Date Received
    November 4, 2022
    Date of Event
    October 6, 2022
    Report Date
    January 12, 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
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND DEVICE EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE LEGAL MANUFACTURER¿S INVESTIGATION, AN OLYMPUS FIELD SERVICE ENGINEER WHO INSPECTED THE SUBJECT DEVICE ON-SITE FOUND THAT THERE WAS NO PROBLEM WITH THE SCOPE GUIDE; HOWEVER, THE CABLE WAS DEFECTIVE AND NEEDED TO BE REPLACED. A ROOT CAUSE FOR THE CABLE FAILURE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. FOLLOW UP WITH THE USER FACILITY IS CURRENTLY BEING PERFORMED TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT. A SUPPLEMENTAL WILL BE SUBMITTED ON COMPLETION OF INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    THE FIELD SERVICE COORDINATOR ON BEHALF OF THE CUSTOMER REPORTED, THE ENDOSCOPE POSITION DETECTING UNIT WAS NOT WORKING DURING A COLONOSCOPY DUE TO WHICH THE PROCEDURE HAD TO BE CANCELLED. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2179076 ENDOSCOPE POSITION DETECTING UNIT ENDOSCOPE POSITION DETECTING UNIT PGU SHIRAKAWA OLYMPUS CO., LTD. UPD-3 04953170331145

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown SCOPE.