BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACHEAL INTUBATION FIBERSCOPE

    MDR report key: 16826948 · Received April 27, 2023

    Report

    Report Number
    9610595-2023-06820
    Event Type
    Malfunction
    Date Received
    April 27, 2023
    Date of Event
    March 29, 2023
    Report Date
    June 24, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    EOQ
    UDI-DI
    04953170340192
    PMA / PMN Number
    K981543
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S INVESTIGATION. 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 INVESTIGATION, THE ROOT CAUSE OF THE REPROCESSING ISSUE WAS THE FACILITY STAFF DID NOT KNOW THAT THE MODIFIED OER-2 CONNECTING TUBE SHOULD NOT BE USED FOR OER-3 FOR REPROCESSING. THERE IS A POSSIBILITY THAT THE MODIFIED CONNECTING TUBE FOR QER-2 WAS USED FOR OER-3 AND REPROCESSED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, WHEN CLEANING THE TRACHEAL INTUBATION FIBERSCOPE WITH ENDOSCOPE REPROCESSOR, THE DEVICE WAS IMPROPERLY AND INSUFFICIENTLY REPROCESSED AND CLEANED BY CONNECTING A MODIFIED MAJ-829-LEAK TEST AIR TUBE FOR THE ENDOSCOPE REPROCESSOR. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM. RELATED PATIENT IDENTIFIERS: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1155998 TRACHEAL INTUBATION FIBERSCOPE TRACHEAL INTUBATION FIBERSCOPE EOQ AIZU OLYMPUS CO., LTD. LF-DP 2137570 04953170340192

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown MAJ-829 (MODIFIED PRODUCT)| OER-3