BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 12930517 · Received December 4, 2021

    Report

    Report Number
    8010047-2021-15520
    Event Type
    Malfunction
    Date Received
    December 4, 2021
    Date of Event
    November 7, 2021
    Report Date
    December 4, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    PMA / PMN Number
    K011151
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS INSPECTED AT OLYMPUS (B)(4). IT WAS CONFIRMED THAT THERE WAS A SIGN OF INSUFFICIENT OR INCORRECT REPROCESSING THE SUBJECT DEVICE WITH CLOGGING THE AIR/WATER NOZZLE WHICH WAS NOT DEFORMED BUT CLOGGED BY THE FOREIGN OBJECT SUSPECTED TO BE WHITE COTTON WOOL. OLYMPUS CHINA WAS RECEIVED THE INFORMATION BY THE USER WHICH THE USER HAD REPROCESSED ACCORDING TO CORRECT PROCEDURE BEFORE THE UNSPECIFIED DIAGNOSTIC PROCEDURE. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE ROOT CAUSE OF THE REPORTED PHENOMENON COULD NOT BE IDENTIFIED. HOWEVER BASED ON THE REPORT OF OLYMPUS (B)(4) AND IT SAID THAT THE FOREIGN OBJECT THAT WAS SUSPECTED TO BE WHITE COTTON WOOL, OMSC PRESUMED THAT THE REPORTED PHENOMENON OCCURRED BY THE FOLLOWING MECHANISM; I) FIBERS FROM WASTE CLOTH AND PAPER TOWELS USED IN THE REPROCESS ENTERED THE AIR/WATER CHANNELS OF THE SUBJECT DEVICE. II) THE FIBERS THAT ENTERED THE AIR/WATER CHANNEL REACHED THE NOZZLE AND BECAME CLOGGED. [NOTES] SINCE THE INSTRUCTIONS FOR SAFE USE (IFU/REPROCESSING MANUAL) HAS THE FOLLOWING DESCRIPTION, IT IS PROBABLE THAT THE REPORTED PHENOMENON COULD BE PREVENTED. 1.4 PRECAUTIONS: ALL CHANNELS OF THE ENDOSCOPE, INCLUDING THE INSTRUMENT CHANNEL AND THE AUXILIARY WATER CHANNEL, AND ALL ACCESSORIES USED WITH THE ENDOSCOPE DURING THE PATIENT PROCEDURE, SUCH AS ALL VALVES AND THE AUXILIARY WATER TUBE (MAJ-855), MUST BE REPROCESSED AFTER EACH PATIENT PROCEDURE, EVEN IF THE CHANNELS OR ACCESSORIES WERE NOT USED DURING THE PATIENT PROCEDURE. INSUFFICIENT REPROCESSING OF THESE COMPONENTS MAY POSE AN INFECTION CONTROL RISK TO PATIENTS AND/OR OPERATORS. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING THE INCOMING INSPECTION FOR REPAIR AT OLYMPUS (B)(4), IT WAS FOUND A SIGN OF INSUFFICIENT OR INCORRECT REPROCESSING THE SUBJECT DEVICE WITH CLOGGING THE AIR/WATER NOZZLE OF THE SUBJECT DEVICE (THE USER MAY HAVE USED THE POOR REPROCESSING SUBJECT DEVICE FOR NEXT PROCEDURE). THE SUBJECT DEVICE HAD BEEN RETURNED TO OLYMPUS (B)(4) FOR REPAIR OF THE AIR/WATER NOZZLE MALFUNCTION WITH CLOGGING. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1828405 EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-H260

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown