BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE BIOPSY VALVE (STERILE)

    MDR report key: 8144678 · Received December 7, 2018

    Report

    Report Number
    2951238-2018-00751
    Event Type
    Malfunction
    Date Received
    December 7, 2018
    Date of Event
    November 19, 2018
    Report Date
    March 8, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    UDI-DI
    14953170152433
    PMA / PMN Number
    K061313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO MAKE A CORRECTION ON THE PROCODE FROM EOB TO EOQ.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED. HOWEVER, BASED ON SIMILAR REPORTS, THE MOST LIKELY CAUSE IS EXCESSIVE STRESS APPLIED TO THE SUBJECT DEVICE DUE TO THE FACILITY'S HANDLING OF AN ENDOTHERAPY ACCESSORY OR SYRINGE SUCH AS FORCIBLE INSERTION/ WITHDRAWING THROUGH THE VALVE. THE MAJ-210 INSTRUCTION MANUAL PROVIDES USERS WARNINGS IN SECTION ¿7.5 INSERTING AND WITHDRAWING THE ENDO-THERAPY ACCESSORIES¿ IN AN EFFORT TO PREVENT DAMAGE TO THE VALVE. ¿ INSERT THE ENDO-THERAPY ACCESSORY INTO THE VALVE AS STRAIGHT AS POSSIBLE. ¿ ANGLED INSERTION AND WITHDRAWAL OF THE ENDO-THERAPY ACCESSORY CAN CAUSE EXCESSIVE RESISTANCE, AND THE ENDO-THERAPY ACCESSORY OR BIOPSY VALVE COULD BE DAMAGED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A DIAGNOSTIC BRONCHOSCOPY PROCEDURE, A PIECE OF BLACK RUBBER WAS FOUND IN THE PATIENT¿S LUNG. THE BLACK RING WAS RETRIEVED THE WITH IRRIGATION AND PLACED IN A SPECIMEN CONTAINER. THE INTENDED PROCEDURE WAS COMPLETED WITH THE SAME EQUIPMENT. THERE WAS NO PATIENT INJURY REPORTED. THE PATIENT WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980425 SINGLE USE BIOPSY VALVE (STERILE) SINGLE USE BIOPSY VALVE EOQ OLYMPUS MEDICAL SYSTEMS CORP. MAJ-210 H7213 14953170152433

    Patients

    Seq Age Sex Outcome Treatment
    1