BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIO SLIM

    MDR report key: 16708876 · Received April 10, 2023

    Report

    Report Number
    3005099803-2023-01752
    Event Type
    Malfunction
    Date Received
    April 10, 2023
    Date of Event
    March 22, 2023
    Report Date
    May 15, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FHQ
    UDI-DI
    08714729842224
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE CODE A050502 CAPTURES THE REPORTABLE EVENT OF DEVICE MISFIRED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPIO SLIM DEVICE WAS USED DURING A SACROSPINOUS FIXATION PROCEDURE PERFORMED ON (B)(6) 2023, FOR THE TREATMENT OF PELVIC ORGAN PROLAPSE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE CARRIER EXTENDED WITHOUT ACTUATING THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPIO SLIM DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPIO SLIM DEVICE WAS USED DURING A SACROSPINOUS FIXATION PROCEDURE PERFORMED ON (B)(6) 2023, FOR THE TREATMENT OF PELVIC ORGAN PROLAPSE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE CARRIER EXTENDED WITHOUT ACTUATING THE DEVICE. ADDITIONALLY, THE SUTURE DART WAS NOT CAUGHT IN THE CAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPIO SLIM DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1531719 CAPIO SLIM HOLDER, NEEDLE, GASTROENTEROLOGIC FHQ BOSTON SCIENTIFIC CORPORATION M0068318261 0030295536 08714729842224

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female