BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 4

    MDR report key: 19950075 · Received August 9, 2024

    Report

    Report Number
    3005099803-2024-03787
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Date of Event
    July 4, 2024
    Report Date
    August 9, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    BWH
    UDI-DI
    08714729792864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A051104 CAPTURES THE REPORTABLE EVENT OF JAWS FAILURE TO CLOSE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 PULMONARY FORCEPS WAS USED DURING A THORACOSCOPIC BIOPSY PROCEDURE ON (B)(6) 2024. DURING THE PROCEDURE, THE FORCEPS COULD NOT BE CLOSED, AND BIOPSY COULD NOT BE EXTRACTED NORMALLY. THE PROCEDURE WAS COMPLETED USING ANOTHER RADIAL JAW 4 PULMONARY FORCEPS. THERE ARE NO KNOWN PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2485267 RADIAL JAW 4 FORCEPS, BIOPSY, BRONCHOSCOPE (NON-RIGID) BWH BOSTON SCIENTIFIC CORPORATION M00515181 0032166381 08714729792864

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male