BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 3211221 · Received July 8, 2013

    Report

    Report Number
    3005099803-2013-05543
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 18, 2013
    Report Date
    June 11, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE IS UNKNOWN; HOWEVER, THE PATIENT WAS REPORTED TO BE OVER 18 YEARS OLD. INVESTIGATION RESULT OF CLIP MASHED ONTO THE BUSHING. A VISUAL EXAMINATION OF THE RETURNED DEVICE NOTED THAT THE CLIP ASSEMBLY WAS MASHED ONTO THE BUSHING AND THE CLIP ASSEMBLY COULD NOT BE DEPLOYED. THE PRONGS COULD NOT BE OPENED OR CLOSED BUT WERE NOT LOCKED INTO THE CAPSULE. THERE WAS A KINK IN THE CONTROL WIRE. BASED ON THE EVALUATION CONDUCTED AND THE DETAILS OF THE COMPLAINT, THESE FAILURES WERE LIKELY CAUSED BY HANDLING OF THE DEVICE WITHOUT PATIENT CONTACT DURING UNPACKING/PREPARATION. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS HANDLING DAMAGE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE CONFIRMED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED BATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USE DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE IN THE FUNDUS ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING PREPARATION OUTSIDE OF THE PATIENT, THE NURSE CLOSED THE CLIP, BUT COULD NOT REOPEN IT. THEREFORE, THE CLIP WAS NOT USED IN THE PATIENT. ANOTHER RESOLUTION CLIP WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED AS BEING STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309840 RESOLUTION CLIP CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522602 ML000383C3

    Patients

    Seq Age Sex Outcome Treatment
    1