BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLIER, SURGICAL, CLIP

    MDR report key: 6215709 · Received December 30, 2016

    Report

    Report Number
    6215709
    Event Type
    Malfunction
    Date Received
    December 30, 2016
    Report Date
    November 16, 2016
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INCIDENT OCCURRED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE FOR GI BLEED AT A BEDSIDE TRAVEL CASE IN ICU. MD REQUESTED METAL CLIPS FOR PROCEDURE TO CLAMP OFF BLEEDING DUODENAL ULCER. A TOTAL OF FOUR CLIPS DEPLOYED IN THE BODY. TWO FELL OFF AND OF THE TWO A BENT CLIP WAS RETRIEVED FROM THE BODY WITH BIOPSY FORCEPS. THE OTHER WAS LEFT TO PASS THROUGH THE BODY. THE TWO REMAINING CLIPS WERE PLACED SUCCESSFULLY ON THE BLEEDING ULCER. FIVE ADDITIONAL CLIPS WERE USED AND PLACED INSIDE OF THE SCOPE BUT FAILED TO FUNCTION BY NOT OPENING AT THE SITE OF THE ULCER. CLIPS WERE REMOVED FROM THE SCOPE AND CHECKED TO SEE IF THEY WOULD DEPLOY OUTSIDE OF SCOPE. ALL EXCEPT ONE DEPLOYED. THAT ONE FAILED TO OPEN. FAILED CLIPS: BOSTON SCIENTIFIC LOT# ML001317C5 EXP 08/05/2019 (BENT INSIDE BODY AND RETRIEVED WITH A BIOPSY FORCEPS, NO HARM REACHED PATIENT), BOSTON SCIENTIFIC LOT# ML001249C5 EXP. 04/29/2019, COOK MEDICAL LOT# W3729283 EXP. 06/02/2019, COOK MEDICAL LOT#W3671499 EXP. 1/14/1209, COOK MEDICAL LOT#W3691687 EXP. 02/28/2019, COOK MEDICAL LOT#W3705393 EXP 04/01/2019. SUCCESSFUL CLIPS: BOSTON SCIENTIFIC LOT#ML001317C5 EXP 08/05/2019 (CLIPPED ON ULCER), COOK MEDICAL LOT#W3705393 EXP. 04/01/2019 (CLIPPED ON ULCER). DEPLOYED CORRECTLY BUT UNABLE TO CLAMP ON ULCER AND LEFT TO PASS THROUGH BODY: BOSTON SCIENTIFIC LOT#ML001317C5 EXP. 08/05/2019. A TOTAL OF NINE CLIPS USED. ALL INDIVIDUAL LOT NUMBERS LISTED ABOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866247 APPLIER, SURGICAL, CLIP GDO BOSTON SCIENTIFIC CORPORATION ML001317C5

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR