BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPECT PULMONARY OLYMPUS 22GA - BOX 5

    MDR report key: 18014738 · Received October 26, 2023

    Report

    Report Number
    3005099803-2023-05779
    Event Type
    Malfunction
    Date Received
    October 26, 2023
    Date of Event
    August 1, 2023
    Report Date
    October 26, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EOQ
    UDI-DI
    08714729861430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT EVENT DATE UNKNOWN, EVENT OCCURRED IN (B)(6) 2023. BLOCK G4: PREMARKET / 510(K) #: K163248 & K151895 BLOCK H6: IMDRF DEVICE CODE A180104 CAPTURES THE REPORTABLE EVENT OF FOREIGN MATERIAL PRESENT IN DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY NEEDLE WAS USED DURING A PROCEDURE PERFORMED IN (B)(6) 2023. DURING THE PROCEDURE, THE NEEDLE GOT STUCK IN THE SHEATH. PRESSURE WAS APPLIED AND THE NEEDLE EXTENDED WITH SOME FOREIGN STEEL COMPONENTS. ALSO, THE STYLET WAS HARD TO REINSERT INTO THE NEEDLE DUE TO SOME FOREIGN COMPONENTS IN THE LUMEN OF THE NEEDLE. THE PROCEDURE WAS COMPLETED USING A NON-BOSTON SCIENTIFIC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1433307 EXPECT PULMONARY OLYMPUS 22GA - BOX 5 BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ BOSTON SCIENTIFIC CORPORATION M00558221 0031518015 08714729861430

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown