BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIBERSCOPE "LF-TP", SET E

    MDR report key: 8547687 · Received April 24, 2019

    Report

    Report Number
    8010047-2019-01830
    Event Type
    Injury
    Date Received
    April 24, 2019
    Report Date
    May 30, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    PMA / PMN Number
    K981543
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY AND WAS REPORTED NO MICROBES WAS DETECTED FROM THE WATER SAMPLES COLLECTED FROM THE FOLLOWING FOUR AUTOMATED ENDOSCOPE REPROCESSORS POSSESSED BY THE USER FACILITY; OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR MODEL ETD3 (S/N (B)(4), NOT AVAILABLE IN THE USA). OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR MODEL ETD3 (S/N (B)(4), NOT AVAILABLE IN THE USA). OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR MODEL ETD3 (S/N (B)(4), NOT AVAILABLE IN THE USA). OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR MODEL MINIETD2 (S/N (B)(4), NOT AVAILABLE IN THE USA). THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) BUT WAS RETURNED TO OLYMPUS EUROPA SE & CO. KG (OEKG). OEKG SENT THE SUBJECT DEVICE TO A THIRD PARTY LABORATORY FOR MICROBIOLOGICAL TESTING. AS A RESULT OF THE TESTING, NO MICROBE WAS DETECTED FROM THE SAMPLE COLLECTED FROM THE INSTRUMENT CHANNEL AND THE DISTAL END OF THE SUBJECT DEVICE. IN ADDITION, OEKG EVALUATED THE SUBJECT DEVICE AND CONFIRMED THAT THERE WAS NO IRREGULARITY IN THE SUBJECT DEVICE. 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 AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IN THIS REPORT HAS NOT BEEN RETURNED TO OMSC FOR EVALUATION. 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.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT AS A RESULT OF MICROBIOLOGICAL TESTING BY THE USER FACILITY, THE SAMPLE COLLECTED FROM THE SUBJECT DEVICE TESTED POSITIVE FOR PSEUDOMONAS AERUGINOSA (THE USER FACILITY DID NOT PROVIDE THE NUMBER OF PSEUDOMONAS AERUGINOSA), AND PSEUDOMONAS AERUGINOSA DETECTED IN BRONCHO ALVEOLAR LAVAGE (BAL) SAMPLES COLLECTED FROM THREE PATIENTS AFTER AN UNSPECIFIED DIAGNOSTIC USING THE SUBJECT DEVICE. THE USER FACILITY SUSPECTS THAT THERE IS A POSSIBILITY OF INFECTION BY THE SUBJECT DEVICE. THE SUBJECT DEVICE HAD BEEN REPROCESSED WITH ANY OF THE FOLLOWING AERS USING PERACETIC ACID. OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR MODEL ETD3 (S/N (B)(4), NOT AVAILABLE IN THE USA). OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR MODEL ETD3 (S/N (B)(4), NOT AVAILABLE IN THE USA). OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR MODEL MINIETD2 (S/N (B)(4), NOT AVAILABLE IN THE USA). OTHER DETAILED INFORMATION WAS NOT PROVIDED AT PRESENT. THE PATIENT'S CONDITION IS CURRENTLY UNKNOWN. OMSC IS SUBMITTING THREE MEDICAL DEVICE REPORTS ACCORDING TO THE NUMBER OF THE PATIENTS. THIS IS ONE OF THREE REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339211 FIBERSCOPE "LF-TP", SET E TRACHEAL INTUBATION FIBERSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. LF-TP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other