BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEAL BIOPSY VALVE

    MDR report key: 14717030 · Received June 16, 2022

    Report

    Report Number
    3005099803-2022-03239
    Event Type
    Malfunction
    Date Received
    June 16, 2022
    Date of Event
    May 25, 2022
    Report Date
    June 16, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OCX
    UDI-DI
    08714729981596
    PMA / PMN Number
    K182275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE MANUFACTURE DATE: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE IS NOT AVAILABLE FOR RETURN; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEAL BIOPSY VALVE WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE SEAL BIOPSY VALVE WAS LEAKING AND POPPING OFF FROM THE ENDOSCOPE WHEN THE SLIP TIP SYRINGE WAS REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254946 SEAL BIOPSY VALVE ENDOSCOPIC IRRIGATION/SUCTION SYSTEM OCX BOSTON SCIENTIFIC CORPORATION SBC-501 08714729981596

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown