BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 6092645 · Received November 10, 2016

    Report

    Report Number
    3005099803-2016-03479
    Event Type
    Malfunction
    Date Received
    November 10, 2016
    Date of Event
    October 24, 2016
    Report Date
    October 24, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KOG
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. (B)(4). 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.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT #3005099803-2016-03477 ADDRESSES THE FIRST RESOLUTION CLIP, MANUFACTURER REPORT #3005099803-2016-03478 ADDRESSES THE SECOND RESOLUTION CLIP AND MANUFACTURER REPORT #3005099803-2016-03479 ADDRESSES THE THIRD RESOLUTION CLIP. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE RESOLUTION CLIP DEVICES WERE USED IN THE STOMACH DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP WAS ABLE TO CLOSE AND DEPLOY FROM THE CATHETER; HOWEVER, AS THE CATHETER WAS PULLED AWAY FROM THE TISSUE THE CLIP JAWS REOPENED AND FELL INSIDE THE PATIENT IN AN OPEN STATE. THE SAME EVENT OCCURRED WITH THE OTHER TWO CLIPS. THE CLIPS WERE LEFT TO PASS NATURALLY AND THE PROCEDURE WAS COMPLETED WITH A FOURTH 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
    744670 RESOLUTION CLIP CLIPPING DEVICE ENDOSCOPE AND/OR ACCESSORIES KOG BOSTON SCIENTIFIC - MARLBOROUGH M00522612

    Patients

    Seq Age Sex Outcome Treatment
    1