BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAJ-1351 (E) BALLOON

    MDR report key: 6415178 · Received March 17, 2017

    Report

    Report Number
    2951238-2017-00164
    Event Type
    Malfunction
    Date Received
    March 17, 2017
    Date of Event
    February 23, 2017
    Report Date
    March 8, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    PSV
    PMA / PMN Number
    PK042140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    OLYMPUS CONTACTED THE USER FACILITY TO OBTAIN MORE INFORMATION REGARDING THE REPORT EVENT AND WAS INFORMED THAT THE REMAINING BALLOONS WERE DISCARDED FOLLOWING THE PROCEDURE. THE USER FACILITY REPORTED THAT THERE WAS NO DEVICE FRAGMENT LEFT INSIDE THE PATIENT AND ACCORDING TO THE USER FACILITY STAFF, THE MOST LIKELY CAUSE OF THE REPORTED EVENT IS NOT COMPLETELY DEFLATING THE BALLOON PRIOR TO WITHDRAWAL.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCECEDURE, ONE BALLOON BURST WHILE WITHDRAWING THE SCOPE FROM THE PATIENT'S AIRWAY. THE DOCTOR WAS ABLE TO EXTRACT THE BALLOON PIECES FROM THE PATIENT. THE INTENDED PROCEDURE WAS COMPLETED, AND THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195643 MAJ-1351 (E) BALLOON BALLOON PSV OLYMPUS MEDICAL SYSTEMS CORP. MAJ-1351 67K

    Patients

    Seq Age Sex Outcome Treatment
    1 EBUS MODEL UNKNOWN