BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II BRONCHOVIDEOSCOPE

    MDR report key: 6770012 · Received August 7, 2017

    Report

    Report Number
    8010047-2017-01158
    Event Type
    Malfunction
    Date Received
    August 7, 2017
    Date of Event
    July 7, 2017
    Report Date
    March 15, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    PMA / PMN Number
    PK061313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) BUT WAS RETURNED TO OLYMPUS (B)(4). AS A RESULT OF THIS DEVICE CONFIRMATION BY (B)(4), THEY FOUND THAT THE DISTAL END OF THIS DEVICE WAS SEVERELY BURNT. FROM THE ABOVE, IT IS CONSIDERED THAT THIS CASE OCCURRED BY PERFORMING APC (ARGON PLASMA COAGULATION) OPERATION NEAR THE DISTAL END OF THIS DEVICE DUE TO INCORRECT HANDLING BY THE USER FACILITY.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS SUBMITTING TO CORRECT "DEVICE PRODUCT CODE".

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OMSC. OMSC REVIEWED THE MANUFACTURING HISTORY OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT AFTER USING THE SUBJECT DEVICE TO APC(ARGON PLASMA COAGULATION) PROCEDURE FOR THERAPEUTIC, THE USER FACILITY NOTICED THAT THE DISTAL END OF THIS PRODUCT WAS DAMAGED AND FOUND A PART OF THE MISSING PARTS OUTSIDE THE PATIENT'S BODY. THE USER FACILITY COULDN'T FIND THE REST OF THE MISSING PARTS, SO THE USER FACILITY CHECKED THE INSIDE OF THE PATIENT BUT COULDN'T FIND IT. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550181 EVIS EXERA II BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. BF-1T180

    Patients

    Seq Age Sex Outcome Treatment
    1