BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIO SLIM

    MDR report key: 22062013 · Received May 21, 2025

    Report

    Report Number
    2124215-2025-31931
    Event Type
    Malfunction
    Date Received
    May 21, 2025
    Date of Event
    April 24, 2025
    Report Date
    May 21, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PWI
    UDI-DI
    08714729838005
    PMA / PMN Number
    K172060
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE USING A CAPIO SLIM, THE DEVICE DID NOT FIRE CORRECTLY. NO PATIENT COMPLICATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81748 CAPIO SLIM SPECIALIZED SURGICAL INSTRUMENTATION FOR USE WITH UROGYNECOLOGIC SURGICAL MESH PWI BOSTON SCIENTIFIC CORPORATION M0068318250 0035706034 08714729838005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown