BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIO SLIM

    MDR report key: 19576764 · Received June 20, 2024

    Report

    Report Number
    2124215-2024-36593
    Event Type
    Malfunction
    Date Received
    June 20, 2024
    Date of Event
    May 29, 2024
    Report Date
    July 19, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PWI
    UDI-DI
    08714729842224
    PMA / PMN Number
    K172060
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK H6: IMDRF DEVICE CODE A050502 CAPTURES THE REPORTABLE EVENT OF DEVICE MISFIRE. BLOCK H11: CORRECTION: BLOCKS D2A, D2B, G4, AS WELL AS E1, E2 AND E3 (INITIAL REPORTER FIELDS) HAVE BEEN UPDATED.

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK H6: IMDRF DEVICE CODE A050502 CAPTURES THE REPORTABLE EVENT OF DEVICE MISFIRE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE CAPIO DEVICE HAS MISFIRED ON MULTIPLE DIFFERENT OCCASIONS. THERE WAS NO INFORMATION ON WHAT COMPLETED THE PROCEDURE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE CAPIO DEVICE MISFIRED ON MULTIPLE DIFFERENT OCCASIONS. THERE WAS NO INFORMATION ON WHAT COMPLETED THE PROCEDURE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1551854 CAPIO SLIM SPECIALIZED SURGICAL INSTRUMENTATION FOR USE WITH UROGYNECOLOGIC SURGICAL MESH PWI BOSTON SCIENTIFIC CORPORATION M0068318261 0033424886 08714729842224
    1655039 CAPIO SLIM SPECIALIZED SURGICAL INSTRUMENTATION FOR USE WITH UROGYNECOLOGIC SURGICAL MESH PWI BOSTON SCIENTIFIC CORPORATION M0068318261 0033424886 08714729842224

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown