BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPECT PULMONARY OLYMPUS 25GA - BOX 5

    MDR report key: 20925535 · Received December 13, 2024

    Report

    Report Number
    3005099803-2024-06274
    Event Type
    Malfunction
    Date Received
    December 13, 2024
    Date of Event
    November 20, 2024
    Report Date
    December 13, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EOQ
    UDI-DI
    08714729861447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK G4: PREMARKET / 510(K) #: K163248 & K151895. BLOCK H6: IMDRF DEVICE CODE A0501 IS BEING USED TO CAPTURE THE REPORTABLE ISSUE OF DISTAL TIP BROKE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY NEEDLE WAS USED IN THE AIRWAY DURING PROCEDURE ON (B)(6) 2024. DURING THE PROCEDURE, THE DISTAL TIP BROKE AFTER BIOPSYING A LYMPH NODE. THE PROCEDURE WAS COMPLETED USING ANOTHER EXPECT PULMONARY NEEDLE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1937069 EXPECT PULMONARY OLYMPUS 25GA - BOX 5 BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ BOSTON SCIENTIFIC CORPORATION M00558251 0034956000 08714729861447

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown