BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRACHEAL INTUBATION FIBERSCOPE

    MDR report key: 2893204 · Received December 18, 2012

    Report

    Report Number
    8010047-2012-00443
    Event Type
    Injury
    Date Received
    December 18, 2012
    Date of Event
    October 1, 2012
    Report Date
    January 20, 2016
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP
    Product Code
    EOQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC) PERFORMED A MDR RETROSPECTIVE REVIEW AND OMSC FOUND THAT THIS SUPPLEMENTAL REPORT IS REQUIRED. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR ADDING THE FOLLOWING CONTEXTS; TO PUT CHECK MARK IN "OTHER SERIOUS", BECAUSE IT WAS REPORTED THAT THE PATIENT TESTED POSITIVE FOR PSEUDOMONAS AERUGINOSA. TO CORRECT THE DATE OF "RETURNED TO MANUFACTURER" FROM "12/05/2012" TO "11/30/2012." TO CORRECT FROM "OTHER" TO "SERIOUS INJURY". PLEASE CROSS-REFERENCE MFR. REPORT# 8010047-2012-00440, 8010047-2012-00442, AND 8010047-2012-00444.

    Additional Manufacturer Narrative · 1

    OLYMPUS SALES REPRESENTATIVE VISITED THE USER FACILITY, AND REVIEWED THE USER FACILITY'S REPROCESSING METHOD, AND NOTED THAT THE USERS DIDN'T REPROCESS A DEVICE IMMEDIATELY AFTER AP PROCEDURE AND LEFT IT DIRTY FOR A NIGHT. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION FOUND A SLIGHT RESIDUE IN THE INSTRUMENT CHANNEL PORT. AT THE PRESENT TIME, THE EXACT CAUSE OF THE REPORTED PHENOMENON CANNOT BE DETERMINED, HOWEVER INSUFFICIENT REPROCESSING AND USER HANDLING CANNOT BE RULED OUT AS CONTRIBUTORY FACTORS. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION. CROSS-REFERENCE MFR. REPORT # 8010047-2012-00440, 00442, 00444 FOR OTHER RELATED REPORTS.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO HAVE IDENTIFIED SPUTUM OF A PT THAT UNDERWENT AN INTUBATION PROCEDURE AT THE FACILITY AND TESTED POSITIVE FOR PSEUDOMONAS AERUGINOSA. THE USER FACILITY FURTHER REPORTED THAT 3 DEVICES INCLUDING THE SUBJECT DEVICE HAD BEEN CULTURED AND TESTED POSITIVE AND OTHER 3 PTS HAD BEEN EXAMINED WITH THE DEVICES. THERE WAS NO REPORT OF INFECTION OR OTHER PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    0 TRACHEAL INTUBATION FIBERSCOPE TRACHEAL INTUBATION SCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP LF-TP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other