BEUDAMED
    FDA Adverse Event Summary report: N

    ADVANCE CAPSULE DELIVERY DEVICE

    MDR report key: 2933143 · Received January 11, 2013

    Report

    Report Number
    1528319-2013-00001
    Date Received
    January 11, 2013
    Date of Event
    November 9, 2012
    Report Date
    January 11, 2013
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    US ENDOSCOPY HAS CONDUCTED AN INVESTIGATION INTO THE MEDWATCH REPORT FILED BY THE FACILITY. US ENDOSCOPY HAS CONFIRMED WITH THE USER FACILITY THAT THE DEVICE WAS USED DURING AN EGD PROCEDURE. NO PATIENT INJURY OCCURRED AND NO INTERVENTION WAS NEEDED TO PREVENT PATIENT OR USER HARM. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE, AND THE EVENT DID NOT RESULT IN ANY DELAY. THE ACTUAL DEVICE INVOLVED WAS NOT RETURNED FOR INVESTIGATION. 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. ON (B)(6) 2012, US ENDOSCOPY RECEIVED A MEDWATCH REPORT STATING THE FOLLOWING: ENDOSCOPY CAPSULE DEPLOYMENT DEVICE FAILED TO DEPLOY CAPSULE. ADDITIONALLY, THE REPORT INDICATED THERE WAS AN INJURY AND THAT INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19509 ADVANCE CAPSULE DELIVERY DEVICE ADVANCE CAPSULE DELIVERY DEVICE KOG UNITED STATES ENDOSCOPY GROUP, INC. 00711144 55682

    Patients

    Seq Age Sex Outcome Treatment
    1