BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAJ-210 (20PCS)

    MDR report key: 5773400 · Received July 6, 2016

    Report

    Report Number
    2951238-2016-00583
    Event Type
    Malfunction
    Date Received
    July 6, 2016
    Date of Event
    May 30, 2016
    Report Date
    March 8, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    PMA / PMN Number
    PK981543
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED; HOWEVER, THE MOST LIKELY CAUSE OF THE REPORTED DEVICE DAMAGE COULD BE ATTRIBUTED TO THE OPERATOR'S TECHNIQUE. THE INSTRUCTION MANUAL CONTAINS CAUTION STATEMENTS IN AN EFFORT TO PREVENT EQUIPMENT DAMAGE. "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." AS PART OF OUR INVESTIGATION OF THIS REPORT, OLYMPUS MADE MULTIPLE FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS OBTAINED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A DIAGNOSTIC BRONCHOSCOPY PROCEDURE, SINGLE USE BIOPSY VALVE DEBRIS WAS FOUND IN THE LUNG OF THE PATIENT. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427912 MAJ-210 (20PCS) SINGLE USE BIOPSY VALVE EOQ OLYMPUS MEDICAL SYSTEMS CORP. MAJ-210 NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1