BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIO SLIM

    MDR report key: 23632931 · Received November 24, 2025

    Report

    Report Number
    2124215-2025-85568
    Event Type
    Malfunction
    Date Received
    November 24, 2025
    Date of Event
    October 28, 2025
    Report Date
    November 24, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PWI
    UDI-DI
    08714729838005
    PMA / PMN Number
    K172060
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CAPIO DEVICE MISFIRED DURING THE PROCEDURE, AND AN ALTERNATE DEVICE WAS USED TO COMPLETE IT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2323312 CAPIO SLIM SPECIALIZED SURGICAL INSTRUMENTATION FOR USE WITH UROGYNECOLOGIC PWI BOSTON SCIENTIFIC CORPORATION M0068318250 0036847657 08714729838005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female