BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIRANHA

    MDR report key: 17207874 · Received June 27, 2023

    Report

    Report Number
    3005099803-2023-03354
    Event Type
    Malfunction
    Date Received
    June 27, 2023
    Date of Event
    June 1, 2023
    Report Date
    June 27, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCL
    UDI-DI
    08714729302599
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E: THIS EVENT WAS REPORTED BY BSC SALES REP. THE INITIAL REPORTER FACILITY NAME IS: (B)(6) HOSPITAL. H6: IMDRF DEVICE CODE A051104 CAPTURES THE REPORTABLE EVENT OF JAWS FAILED TO CLOSED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PIRANHA WAS USED IN A BIOPSY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE JAWS WERE OPENED BUT UNABLE TO CLOSE. THERE WAS NO PATIENT COMPLICATION AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1220793 PIRANHA FORCEPS, BIOPSY, NON-ELECTRIC FCL BOSTON SCIENTIFIC CORPORATION M0065051600 0029081910 08714729302599

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown