BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPE REPROCESSOR

    MDR report key: 19206073 · Received April 29, 2024

    Report

    Report Number
    9610595-2024-08861
    Event Type
    Malfunction
    Date Received
    April 29, 2024
    Report Date
    June 17, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: ESTABLISHMENT NAME: (B)(6). THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE CORRECTION OF THE INITIAL MDR AND THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. CORRECTED FIELDS: E1 ADDITIONAL INFORMATION: D8 AND H6. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER THREE (3) YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR INSPECTION, AND THEREFORE CUSTOMER'S COMPLAINT COULD NOT BE CONFIRMED. A DEFINITIVE ROOT CAUSE WAS NOT IDENTIFIED, HOWEVER BASED ON THE RESULTS OF THE INVESTIGATION, THE PROBABLE CAUSE OF THE "REPROCESSING BEING PERFORMED WITHOUT ATTACHING A CONNECTING TUBE" MALFUNCTION WOULD LIKELY BE RELATED TO USER THAT MIGHT NOT THOROUGHLY READ THE INSTRUCTION MANUAL, AND REPROCESSING HAD BEEN PERFORMED WITHOUT ATTACHING A CONNECTING TUBE. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: INSTRUCTIONS FOR OER-5, OERATION MANUAL SECTION 4.7 ¿CONNECTING TUBE INSTALLATION¿ TO FIND OUT WHAT CONNECTING TUBES CAN BE USED, REFER TO THE PROVIDED ¿LIST OF COMPATIBLE ENDOSCOPES/CONNECTING TUBES <OER-5>¿. WARNING ATTACH ALL OF THE CONNECTING TUBES SPECIFIED ACCORDING TO THE TYPE OF THE ENDOSCOPE. IF REPROCESSING IS PERFORMED WITHOUT ATTACHING ALL OF THE REQUIRED CONNECTING TUBES, REPROCESSING MAY BE INEFFECTIVE. ALTHOUGH THE ¿LIST OF COMPATIBLE ENDOSCOPES/CONNECTING TUBES <OER-5>¿ SHOWS THE APPLICABLE CONNECTING TUBES FOR EACH ENDOSCOPE, IT MAY NOT LIST THE LATEST ENDOSCOPE MODELS. IF YOUR ENDOSCOPE MODEL IS NOT LISTED, CONTACT OLYMPUS FOR MORE INFORMATION. THIS REPORT IS RELATED TO MFRS: 239810 (1/5), 240406(2/5), 240370 (3/5) AND 241711(4/5) OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE OF THE CONNECTING TUBES WAS NOT CONNECTED TO THE ENDOSCOPE REPROCESSOR DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1277963 ENDOSCOPE REPROCESSOR ENDOSCOPE REPROCESSOR FEB AIZU OLYMPUS CO., LTD. OER-5

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown GF-UCT260 EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE| MAJ-2358 CONNECTING TUBE