BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 6183073 · Received December 16, 2016

    Report

    Report Number
    3005099803-2016-04021
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Date of Event
    November 9, 2016
    Report Date
    November 21, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KOG
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MFG. SITE NAME - (B)(6). ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF SIX DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2016-04019 PERTAINS TO THE FIRST RESOLUTION CLIP DEVICE, MANUFACTURER REPORT # 3005099803-2016-04020 PERTAINS TO THE SECOND RESOLUTION CLIP DEVICE, MANUFACTURER REPORT # 3005099803-2016-04021 PERTAINS TO THE THIRD RESOLUTION CLIP DEVICE, MANUFACTURER REPORT # 3005099803-2016-04024 PERTAINS TO THE FOURTH RESOLUTION CLIP DEVICE, MANUFACTURER REPORT # 3005099803-2016-04022 PERTAINS TO THE FIFTH RESOLUTION CLIP DEVICE, AND MANUFACTURER REPORT # 3005099803-2016-04023 PERTAINS TO THE SIXTH RESOLUTION CLIP DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SIX RESOLUTION CLIP DEVICES WERE USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, ALL THE SIX CLIPS' ARMS WERE BENT UPON DEPLOYMENT AND FELL INSIDE THE PATIENT IN AN OPEN STATE. THE CLIPS WERE THEN LEFT TO PASS NATURALLY. THE PROCEDURE WAS COMPLETED WITH THREE RESOLUTION CLIP DEVICES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832354 RESOLUTION CLIP CLIPPING DEVICE ENDOSCOPE AND/OR ACCESSORIES KOG BOSTON SCIENTIFIC - MARLBOROUGH M00522610 ML001327C5

    Patients

    Seq Age Sex Outcome Treatment
    1