BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIO SLIM

    MDR report key: 21424932 · Received February 20, 2025

    Report

    Report Number
    2124215-2025-06379
    Event Type
    Malfunction
    Date Received
    February 20, 2025
    Date of Event
    December 19, 2024
    Report Date
    February 20, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PWI
    UDI-DI
    08714729842224
    PMA / PMN Number
    K172060
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: DEVICE CODE A050502 CAPTURES THE REPORTABLE EVENT OF A MISFIRED DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE USING A CAPIO SLIM, THE DEVICE MISFIRED. NO PATIENT COMPLICATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394630 CAPIO SLIM SPECIALIZED SURGICAL INSTRUMENTATION FOR USE WITH UROGYNECOLOGIC SURGICAL MESH PWI BOSTON SCIENTIFIC CORPORATION M0068318261 0034735150 08714729842224

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female