BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTOCO2L INSUFFLATION SYSTEM

    MDR report key: 2442929 · Received February 3, 2012

    Report

    Report Number
    2411512-2012-00003
    Event Type
    Injury
    Date Received
    February 3, 2012
    Report Date
    February 2, 2012
    Manufacturer
    E-Z-EM, INC.
    Product Code
    FCX
    PMA / PMN Number
    K030854
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2012: THIS IS ONE OF THREE CASES INVOLVED WITH THE SAME DEVICE AT THE SAME USER FACILITY: THE USER FACILITY STATED THAT THE UNIT'S PRESSURE AT THE OUTLET PORT IS NOT THE SAME PRESSURE AS IS INDICATED ON THE UNIT. THE CUSTOMER REPORTED THAT THE PRESSURE PROBLEM LED TO PERFORATIONS IN THREE PTS. THIS UNIT WAS RECEIVED ON 23-JAN-2012 BY (B)(4) QUALITY ASSURANCE. THE (B)(4) DEVICE UNIT'S ENGINEER PERFORMED FUNCTIONAL TESTING ON THE RETURNED UNIT ON 23-JAN-2012, AND PER THE PROTOCOL PRESSURE AND FLOW TEST FORM, THE UNIT'S FLOW RATE WAS FOUND TO BE OPERATING TO SPEC. THE PRESSURE WAS WITHIN SPEC. IN ADDITION, THE UNIT'S PRESSURE RELIEF VALVES (BOTH ELECTRONIC AND MECHANICAL) WERE TESTED AND FOUND TO BE OPERATING TO SPEC. THE COMPLAINT COULD NOT BE VERIFIED. ON 23-JAN-2012, THIS UNIT WAS SENT BACK TO THE (B)(4) SUPPLIER (B)(4) FOR FURTHER EVAL. TESTING WAS PERFORMED BY (B)(4) ON 24-JAN-2012 AND THE RESULTS ARE AS FOLLOWS: COMPANY COMMENTS: A PT OF UNREPORTED AGE/SEX UNDERWENT A VIRTUAL COLONOSCOPY FOR AN UNREPORTED INDICATION WHICH UTILIZED THE CO2 INSUFFLATOR (PROTOCO2L) AND REPORTEDLY EXPERIENCED PERFORATION DURING THE PROCEDURE. THE RETURNED UNIT TESTING RESULTS FROM (B)(4) AND MFR'S INVESTIGATION SHOWED THAT THE UNIT MET SPECS. DUE TO THE VERY LIMITED INFO PROVIDED, THE EXACT ETIOLOGY OF THE PERFORATION CANNOT BE DETERMINED. FURTHER INFO IS REQUIRED.

    Description of Event or Problem · 1

    THIS IS ONE OF THREE CASES INVOLVED WITH THE SAME DEVICE AT THE SAME USER FACILITY. ON (B)(6) 2012: THE USER FACILITY REPORTED: A PT (NO IDENTIFIER PROVIDED) UNDERWENT A VIRTUAL COLONOSCOPY USING THE PROTOCOL INSUFFLATION SYSTEM AND EXPERIENCED A "PERFORATION." IT WAS REPORTED THAT THE PTS WERE NEVER "INCONTINENT" BY THE PERFORATIONS; THE RADIOLOGIST OBSERVED THE PERFORATIONS WHILE READING THE X-RAYS. NO OTHER INFO WAS PROVIDED. THIS REPORT IS ASSOCIATED WITH THE FOLLOWING REPORT NUMBERS: 2411512-2012-00001 AND 2411512-2012-0002. ADD'L INFO IS REQUIRED. WORLD WIDE CASE ID: (B)(4). THE CUSTOMER'S COMPLAINT OF PRESSURE PROBLEMS COULD NOT BE VERIFIED. THE FLOW AND PRESSURE WERE PERIODICALLY ADJUSTED, AND THE UNIT WAS MONITORED FOR ANY INCONSISTENCY IN THE SET PRESSURE DURING MULTIPLE TESTING (SIC). THE UNIT PERFORMED AS EXPECTED AND MET ALL REQUIRED SPECS OUTLINED PER PROCEDURE. ON (B)(6) 2012, (B)(4) REQUESTED ADD'L INFO. THE SITE WAS VISITED ON (B)(4) 2012 BY A (B)(4) IMAGING REP AND THE SITE WAS WORKING ON THE RESPONSES. AS OF (B)(4) 2012, THE USER FACILITY HAS NOT PROVIDED THE ANSWERS TO (B)(4) FOR THIS PT. ON (B)(6) 2010, THE SAME USER FACILITY REPORTED MICROPERFORATIONS IN FOUR PTS WITH THIS SAME UNIT (SERIAL # (B)(4)). THE PTS EXPERIENCED SLIGHT PAIN, BUT WERE OTHERWISE FINE. THE PTS WERE NOT SENT TO THE EMERGENCY ROOM AND THEY RECOVERED. THE UNIT HAS AN ELECTRONICALLY CONTROLLED PRESSURE RELIEF VALVE AT 50MMHG AND AN INDEPENDENT REDUNDANT MECHANICAL PRESSURE RELIEF VALVE SET TO 75MMHG. DURING INVESTIGATION TESTING, THE UNIT'S ELECTRONIC PRESSURE RELIEF VALVE PERFORMED WITHIN SPECS; HOWEVER, THE MECHANICAL PRESSURE RELIEF VALVE DID NOT MEET SPECS. THE UNIT WAS RECALIBRATED AND RETURNED TO THE SITE. THOSE REPORTS ARE ASSOCIATED WITH THE FOLLOWING MFR REPORT NUMBERS: 2411512-2010-000005, 000006, 000007, AND 000008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTOCO2L INSUFFLATION SYSTEM INSUFFLATOR, AUTOMATIC CARBON DIOXIDE FOR VIRTUAL COLONOSCOPY FCX E-Z-EM, INC. 6400 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other