BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASONIC GASTROVIDEOSCOPE

    MDR report key: 9863671 · Received March 22, 2020

    Report

    Report Number
    8010047-2020-01837
    Event Type
    Malfunction
    Date Received
    March 22, 2020
    Report Date
    May 15, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    ODG
    PMA / PMN Number
    K051541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IN THIS REPORT WAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) BUT WAS RETURNED TO OLYMPUS (B)(4). (B)(4) SENT THE SUBJECT DEVICE TO A THIRD PARTY LABORATORY FOR MICROBIOLOGICAL TESTING. AS A RESULT OF THE TESTING, FOLLOWING MICROBES WERE DETECTED FROM THE SAMPLE COLLECTED FROM THE SUBJECT DEVICE. ALL CHANNELS: GRAM POSITIVE BACTERIA (2CFU/ENDOSCOPE). THE TESTING RESULT CLEARED THE (B)(6) GUIDELINE. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE DEVICE HAD BEEN REPROCESSED WITH A NON-OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR, WASSENBURG WD440 ADAPTASCOPE, USING PERACETIC ACID. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. (B)(4) CHECKED THE SUBJECT DEVICE AND FOUND THE FOLLOWING. THE UNIVERSAL CORD WAS PERFORATED. THE ULTRASONIC TRANSDUCER SURFACE WAS DAMAGED. THE ADHESIVE AT THE BENDING SECTION WAS WORN. THE OPERATING SECTION WAS WORN. THE SWITCH NO.1 WAS WORN AND THE SWITCH NO.2 WAS SCRATCHED. THE UNIVERSAL CORD AND ULTRASONIC CABLE WERE KINKED. THE ANGULATION HAD TOO MUCH PLAY. THE ULTRASONIC TRANSDUCER SURFACE INSULATION TEST FAILED. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT AS A RESULT OF ROUTINE MICROBIOLOGICAL TESTING BY THE USER FACILITY, FOLLOWING MICROBES WERE DETECTED FROM THE SAMPLE COLLECTED FROM THE SUBJECT DEVICE. INSTRUMENT CHANNEL: PSEUDOMONAS AERUGINOSA (130 CFU/100ML). SUCTION CHANNEL: PSEUDOMONAS AERUGINOSA (1,700 CFU/100ML). INSTRUMENT/SUCTION CHANNEL: PSEUDOMONAS AERUGINOSA (2,000 CFU/100ML). THE DEVICE HAD BEEN REPROCESSED USING PERACETIC ACID. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327341 ULTRASONIC GASTROVIDEOSCOPE ULTRASONIC GASTROVIDEOSCOPE ODG OLYMPUS MEDICAL SYSTEMS CORP. GF-UE160-AL5

    Patients

    Seq Age Sex Outcome Treatment
    1