BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP

    MDR report key: 20890975 · Received December 10, 2024

    Report

    Report Number
    3005099803-2024-06180
    Event Type
    Malfunction
    Date Received
    December 10, 2024
    Date of Event
    May 16, 2024
    Report Date
    December 10, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PKL
    UDI-DI
    08714729504795
    PMA / PMN Number
    K222503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. BLOCK H6: IMDRF DEVICE CODE A15 CAPTURES THE REPORTABLE EVENT OF CLIP DOES NOT RELEASE PROPERLY.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE CLIP HEMOSTATIC CLIPPER DOES NOT ALLOW ROTATION ON ITS OWN AXIS, MAKING PROPER POSITION ADJUSTMENT DIFFICULT. THE CLIPPER CLIP DOES NOT PROPERLY RELEASE AFTER FIRING, POTENTIALLY INJURING THE PATIENT DUE TO THE TRACTION OF THE MATERIAL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: PER CONFIRMATION FROM DQA A RESOLUTION CLIP IS NOT DESIGNED TO ROTATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2534053 RESOLUTION CLIP CLIP, HEMOSTATIC PKL BOSTON SCIENTIFIC CORPORATION M00522610 0032685495 08714729504795

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown