BEUDAMED
    FDA Adverse Event Summary report: N

    ENDO SMARTCAP

    MDR report key: 4474624 · Received February 2, 2015

    Report

    Report Number
    1651395-2015-00001
    Date Received
    February 2, 2015
    Report Date
    January 27, 2015
    Manufacturer
    MEDIVATORS
    Product Code
    KOG
    PMA / PMN Number
    K093665
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BRACCO MDR 3500A FORM 2411512-2014-00010 WAS RECEIVED BY (B)(6) RA. THE CASE STATES THAT A FACILITY REPORTED TO BRACCO OF TWO PATIENTS THAT EXPERIENCED COLONIC PERFORATION WHILE USING BRACCO CO2 EFFICIENT INSUFFLATOR. THE FACILITY WAS USING MEDIVATORS' DISPOSABLE TUBE SETS ENDO SMARTCAP 100145CO2 AND EXTENSION TUBING 100551 WITH THE E-Z-EM CO2 EFFICIENT INSUFFLATOR DURING THE PROCEDURES. MEDIVATORS TUBE SETS WERE FOUND TO BE SUBSTANTIALLY EQUIVALENT WHEN TESTED AS A CONDUIT BETWEEN FLUID SOURCE AND ENDOSCOPE WITH E-Z-EM CO2 EFFICIENT INSUFFLATOR AS DESCRIBED IN THE ENDO SMART CAP 510(K) SUBMISSION K093665. ALSO, MEDIVATORS HAS PERFORMANCE TESTING OF THE E-Z-EM CO2 EFFICIENT IN COMPARISON TO THE MEDIVATORS MANUFACTURED CO2 INSUFFLATOR. THE TESTS CONCLUDED THAT MEDIVATORS TUBES SETS ARE COMPATIBLE TO BRACCO'S E-Z-EM CO2 EFFICIENT INSUFFLATOR IN TERMS OF FLOW AND PRESSURE AS WELL AS FREE FLOW MEASUREMENTS THROUGH THE ENDOSCOPE. TEST REPORTS CAN BE FOUND IN MEDIVATORS RA LIBRARY. THERE IS NO ADDITIONAL INFORMATION REGARDING PATIENT STATUS. TO DATE, THERE ARE NO NEW REPORTS OF PATIENT ILLNESS OR INJURY. THIS COMPLAINT WILL CONTINUE TO BE MONITORED WITHIN THE MEDIVATORS COMPLAINT SYSTEM.

    Description of Event or Problem · 1

    BRACCO MEDWATCH FORM RECEIVED FROM (B)(6) SALES REPRESENTATIVE VIA EMAIL. MEDIVATORS PROCEDURAL PRODUCTS P/N 100145-CO2 AND 100551 ARE MENTIONED IN THE EVENT DESCRIPTION OF THE REPORT. TWO PATIENTS EXPERIENCED COLONIC PERFORATION DURING ENDOSCOPY PROCEDURE WHEN USING THE CO2EFFICIENT INSUFFLATOR MANUFACTURED BY BRACCO. THIS MACHINE WAS USED IN CONJUNCTION WITH 100145-CO2 MEDIVATORS ENDO SMARTCAP AND 100551 MEDIVATORS ENDOGATOR EXTENSION TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75626 ENDO SMARTCAP DISPOSABLE WATER BOTTLE TUBING KOG MEDIVATORS 100145-CO2

    Patients

    Seq Age Sex Outcome Treatment
    1 BRACCO CO2 EFFICIENT ENDOSCOPIC INSUFFLATOR