BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE CAPSULE DELIVERY DEVICE

    MDR report key: 3131214 · Received May 23, 2013

    Report

    Report Number
    1528319-2013-00030
    Event Type
    Malfunction
    Date Received
    May 23, 2013
    Date of Event
    April 24, 2013
    Report Date
    May 24, 2013
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED WAS NOT RETURNED FOR INVESTIGATION; THEREFORE, THE ROOT CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED. IN GOOD FAITH EFFORT US ENDOSCOPY HAS ATTEMPTED TO CONTACT THE CUSTOMER ON SEVERAL OCCASIONS TO TRY AND GAIN FURTHER DETAILS AND UNDERSTANDING REGARDING THE INCIDENT. TO DATE US ENDOSCOPY HAS NOT RECEIVED ANY ADDITIONAL INFO.

    Description of Event or Problem · 1

    THE DEVICE IS USED IN THE TRANSENDOSCOPIC DELIVERY OF THE GIVEN PILLCAM SB VIDEO CAPSULE TO THE STOMACH OR DUODENUM IN PTS WHO ARE EITHER UNABLE TO SWALLOW THE VIDEO CAPSULE, OR UNABLE TO PASS THE VIDEO CAPSULE BEYOND THE PYLORUS IN SUFFICIENT TIME TO COMPLETE THE DESIRED DIAGNOSTIC EVAL. US ENDOSCOPY RECEIVED A COMPLAINT THAT THE FACILITY TESTED THE DEVICE OUTSIDE OF THE PT AND IT WORKED FINE. THEY INSERTED THE SCOPE AND PILL CAM INSIDE THE PT, ACTUATED THE HANDLE BUT THE PILL CAM DID NOT DEPLOY. THEY REMOVED THE SCOPE AND PILL CAM AND REINSERTED INTO THE PT AND ACTUATED THE HANDLE. THE PILL CAM AND PLASTIC CUP FELL OFF INSIDE THE PT'S MOUTH. THE PILL CAM AND CUP WERE IMMEDIATELY RETRIEVED. THERE WAS NO REPORTED HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229074 ADVANCE CAPSULE DELIVERY DEVICE ADVANCE CAPSULE DELIVERY DEVICE KOG UNITED STATES ENDOSCOPY GROUP, INC. 00711144 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1