BEUDAMED
    FDA Adverse Event Summary report: N

    PROTOCO2L INSUFFLATION SYSTEM

    MDR report key: 1938659 · Received December 20, 2010

    Report

    Report Number
    2411512-2010-00004
    Date Received
    December 20, 2010
    Date of Event
    November 22, 2010
    Report Date
    December 17, 2010
    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

    THE USER FACILITY PROVIDED THE INFO THAT THE SAME TWO TECHNICIANS WERE INVOLVED IN USING THE DEVICE. THE USER FACILITY WAS CONTACTED AND STATED THAT THERE WERE NO CHANGES IN THE WAY OF INSUFFLATING THE PT AND THE SAME PRESSURE 23 MMHG WAS USED. THE BRACCO FIELD ENGINEER NOTED THAT "THE PROTOCOL EXPERIENCED IRREGULAR AIR PRESSURE" AND NEEDED TO BE FIXED. THE PROTOCO2L INSUFFLATOR (MODEL #6400 WITH SERIAL NUMBER (B)(4)) WAS REPLACED WITH ANOTHER INSUFFLATOR. THE FACILITY NOTED THAT THERE HAVE BEEN NO OTHER PERFORATIONS SINCE THE INSUFFLATOR WAS REPLACED. THE FACILITY IS IN THE PROCESS OF RETURNING THE INSUFFLATOR DEVICE FOR ADD'L TESTING. INVESTIGATION IS PENDING AND TESTING RESULTS WILL BE PROVIDED UPON COMPLETION OF THE EVAL. ADD'L INFO IS REQUIRED. COMPANY COMMENTS: IN-HOUSE INITIAL INVESTIGATION NOTED THAT THE PROTOCO2L UNIT "EXPERIENCED IRREGULAR AIR PRESSURE." FINAL INVESTIGATION RESULTS ARE PENDING.

    Description of Event or Problem · 1

    NARRATIVE: THIS IS ONE OF FOUR CASES INVOLVED WITH THE SAME DEVICE AT THIS SITE: (B)(4) 2010: THE USER FACILITY REPORTED: A (B)(6) MALE, PT, UNDERWENT A VIRTUAL COLONOSCOPY ON (B)(6) 2010 FOR COLON CANCER DETECTION (LOOKING FOR POLYPS) USING A CO2 INSUFFLATOR PUMP AND AN ADMINISTRATION SET CATALOG NUMBER 6470, AND EXPERIENCED A MICRO-PERFORATION OF THE INTESTINE. THE PT'S MEDICAL HISTORY OR UNDERLYING DISEASES WERE NOT REPORTED. FOR VIRTUAL COLONOSCOPY PROCEDURES THE FACILITY INSUFFLATES THE COLON TO 23 MMHG. THERE WERE NO CHANGES MADE IN THE WAY INSUFFLATING THE PTS. FROM THE SCAN IMAGES TAKEN DURING THE VIRTUAL COLONOSCOPY, THE RADIOLOGIST NOTICED SMALL BUBBLES VISIBLE ON THE EXTERIOR OF THE COLON, ALSO DESCRIBED AS THE FORMATION OF A SMALL AIR POCKET (HALF-MOON): "A MICRO PERFORATION SEEMED TO OCCUR, WITH NO OTHER CONSEQUENCES DETECTED BY THE DRS". (IT WAS NOT SPECIFIED IF THE PT HAD ANY OTHER ABNORMALITY OF THE COLON IN THE AREA). THE PT EXPERIENCED SLIGHT PAIN, BUT WAS OTHERWISE FINE. THE PT WAS NOT SENT TO THE ER. THE PT RECOVERED (DATE NOT REPORTED). NO OTHER DETAILS WERE PROVIDED. THIS REPORT IS ASSOCIATED WITH REPORT NUMBERS: 2411512-2010-00005, 00006, 00007. WORLDWIDE CASE ID: (B)(4).

    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. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR PROTOCO2L VC ADMINISTRATION SET