BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 6856979 · Received September 11, 2017

    Report

    Report Number
    2951238-2017-00604
    Event Type
    Injury
    Date Received
    September 11, 2017
    Report Date
    March 1, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    ODG
    PMA / PMN Number
    PK093395
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO MAKE A CORRECTION ON THE PROCODE FROM ITX TO ODG.

    Additional Manufacturer Narrative · 1

    THE SCOPE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. AS PART OF OUR INVESTIGATION, OLYMPUS PERFORMED AN INSTRUMENT SERVICE HISTORY REVIEW TO OBTAIN ADDITIONAL DEVICE INFORMATION. THE SCOPE WAS PURCHASED ON (B)(6) 2016 AND WAS LAST SERVICED (B)(6) 2017. THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED; HOWEVER, THE OPERATORS¿ TECHNIQUE COULD NOT BE RULED OUT AS A CONTRIBUTORY FACTOR TO THE REPORTED EVENT. THE INSTRUCTION MANUAL FOR USE STATES, ¿INSPECT OTHER EQUIPMENT TO BE USED WITH THIS INSTRUMENT AS DESCRIBED IN THEIR RESPECTIVE INSTRUCTION MANUALS. IF THIS INSTRUMENT MALFUNCTIONS, DO NOT USE IT. RETURN IT TO OLYMPUS FOR REPAIR.¿

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A DIAGNOSTIC ENDOSCOPIC ULTRASOUND PROCEDURE, THE PATIENT WAS PERFORATED. IT WAS REPORTED THAT THE (AIR/WATER) VALVE OF THE SCOPE WAS FAULTY CAUSING THE BALLOON TO OVER INFLATE AND EXPLODE INSIDE THE PATIENT. THE IMPACT OF THE EXPLOSION CREATED A PERFORATION ON THE PATIENT. THE PATIENT WAS SENT TO (B)(6). THE PATIENT'S OUTCOME IS UNKNOWN. THIS IS 1 OF 2 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636265 EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG OLYMPUS MEDICAL SYSTEMS CORP. GF-UCT180 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R