BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE CAPSULE DELIVERY DEVICE

    MDR report key: 2854328 · Received November 28, 2012

    Report

    Report Number
    1528319-2012-00028
    Event Type
    Malfunction
    Date Received
    November 28, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 28, 2012
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY HAS REPORTED THAT THERE WAS NO HARM TO THE PATIENT. REVIEW OF THE LOT HISTORY RECORD INDICATES NO PROBLEMS IN THE MANUFACTURING OF THIS DEVICE.

    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 PATIENTS 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 EVALUATION. US ENDOSCOPY RECEIVED A COMPLAINT THAT THE CUSTOMER INITIALLY HAD DIFFICULTY DEPLOYING THE PILL CAM. THE DOCTOR COULD NOT GET THE PILL TO DEPLOY INTO THE DUODENUM AND HAD TO PULL THE DEVICE INTO THE STOMACH TO DEPLOY. THE PATIENT HAD TO BE GIVEN ADDITIONAL MEDICATION TO GET THE PILL TO MOVE ALONG THE DIGESTIVE TRACT. THE FACILITY HAS REPORTED THAT THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCE CAPSULE DELIVERY DEVICE ADVANCE CAPSULE DELIVERY DEVICE KOG UNITED STATES ENDOSCOPY GROUP, INC. 00711144 75940

    Patients

    Seq Age Sex Outcome Treatment
    1