BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION 360 CLIP

    MDR report key: 23782373 · Received December 11, 2025

    Report

    Report Number
    3005099803-2025-06591
    Event Type
    Malfunction
    Date Received
    December 11, 2025
    Date of Event
    November 20, 2025
    Report Date
    December 11, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PKL
    UDI-DI
    08714729875635
    PMA / PMN Number
    K222503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IMDRF DEVICE CODE A150208 CAPTURES THE REPORTABLE EVENT OF CLIP DEPLOYING IN THE SCOPE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION 360 CLIP WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CLIP PREMATURELY DEPLOYED IN THE SCOPE. THEY HAD TO RETRIEVE HALF OF THE CLIP WITH FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER CLIP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1761080 RESOLUTION 360 CLIP HEMOSTATIC METAL CLIP FOR THE GI TRACT PKL BOSTON SCIENTIFIC CORPORATION 54773 0036766373 08714729875635

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown