BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 6078532 · Received November 4, 2016

    Report

    Report Number
    3005099803-2016-03371
    Event Type
    Injury
    Date Received
    November 4, 2016
    Report Date
    October 17, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KOG
    PMA / PMN Number
    K040148
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION RESULTS: A VISUAL EXAMINATION OF THE RETURNED RESOLUTION CLIP DEVICE NOTED THAT THE CLIP WAS FULLY DEPLOYED AND THE CLIP ASSEMBLY WAS NOT RETURNED WITH THE DEVICE. A KINK WAS NOTICED IN THE CONTROL WIRE. THIS FAILURE IS LIKELY DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE LIMITED THE PERFORMANCE OF THE DEVICE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A LABELING REVIEW WAS PERFORMED AND FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2016-03371 PERTAINS TO THE FIRST RESOLUTION CLIP DEVICE AND MANUFACTURER REPORT # 3005099803-2016-03372 PERTAINS TO THE SECOND RESOLUTION CLIP DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO RESOLUTION CLIP DEVICES WERE USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON AN UNKNOWN. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AN AUDIBLE CLICK WAS HEARD WHEN THE CLIP WAS DEPLOYED; HOWEVER, THE CLIP FAILED TO FULLY CLOSE AND LOCK ONTO TISSUE. THE CLIP FELL OFF IN THE COLON IN AN OPEN STATE AND THE DETACHED CLIP WAS RETRIEVED WITH THE USE OF A BIOPSY DEVICE. THE SAME ISSUE OCCURRED WITH THE SECOND RESOLUTION CLIP DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP DEVICE. 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 FINE.

    Description of Event or Problem · 1

    THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2016-03371 PERTAINS TO THE FIRST RESOLUTION CLIP DEVICE AND MANUFACTURER REPORT # 3005099803-2016-03372 PERTAINS TO THE SECOND RESOLUTION CLIP DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO RESOLUTION CLIP DEVICES WERE USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON AN UNKNOWN. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AN AUDIBLE CLICK WAS HEARD WHEN THE CLIP WAS DEPLOYED; HOWEVER, THE CLIP FAILED TO FULLY CLOSE AND LOCK ONTO TISSUE. THE CLIP FELL OFF IN THE COLON IN AN OPEN STATE AND THE DETACHED CLIP WAS RETRIEVED WITH THE USE OF A BIOPSY DEVICE. THE SAME ISSUE OCCURRED WITH THE SECOND RESOLUTION CLIP DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP DEVICE. 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729415 RESOLUTION CLIP CLIPPING DEVICE ENDOSCOPE AND/OR ACCESSORIES KOG BOSTON SCIENTIFIC - MARLBOROUGH M00522612 ML001308C5

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention