BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAJ-1444 (D)

    MDR report key: 6857135 · Received September 11, 2017

    Report

    Report Number
    2951238-2017-00613
    Event Type
    Injury
    Date Received
    September 11, 2017
    Report Date
    March 29, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    ODG
    PMA / PMN Number
    PK971660
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION CONFIRMED THE REPORTED DEVICE MALFUNCTION. A VISUAL INSPECTION ON THE RECEIVED CONDITION OF THE DEVICE NOTED A BIG CUT (CHIP) ON THE RUBBER RING. THERE WERE ALSO CUTS FOUND ON THE PACKING RING. THE CUTS ON THE VALVE PACKING RING AND RUBBER LIKELY CONTRIBUTED TO THE DEVICE MISHANDLING. IN ADDITION, THE VALVE WAS TESTED WITH A TEST SCOPE (GF-UCT180) AND OBSERVED THE BALLOON SELF INFLATE; WHICH CONFIRMS THE REPORTED DEVICE MALFUNCTION.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE AIR / WATER VALVE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED; HOWEVER, THE OPERATORS¿ TECHNIQUE COULD NOT BE RULED OUT AS A CONTRIBUTORY FACTOR. THE INSTRUCTION MANUAL FOR USE STATES, ¿BEFORE EACH PROCEDURE, PREPARE AND INSPECT THIS INSTRUMENT AS INSTRUCTED BELOW. 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 2 OF 2 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635479 MAJ-1444 (D) AIR/WATER BUTTUN ODG OLYMPUS MEDICAL SYSTEMS CORP. MAJ-1444 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R