BEUDAMED
    FDA Adverse Event Other Summary report: N

    PNEUMO SURE HIGH FLOW INSUFFLATOR

    MDR report key: 1023640 · Received March 31, 2008

    Report

    Report Number
    2936485-2008-00018
    Event Type
    Other
    Date Received
    March 31, 2008
    Date of Event
    February 8, 2008
    Report Date
    March 19, 2008
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FCX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY OF EVALUATION: PRODUCT RECEIVED. INVESTIGATION IRRITATED. THE UNIT WAS TESTED FOR FUNCTIONALITY IN BOTH THE PEDIATRIC AND HIGH FLOW MODE USING DEFAULT SETTINGS. AS THE TUBESET WAS NOT RETURNED WITH THE COMPLAINT UNIT, AND IN-HOUSE TUBESET WAS USED FOR THE TESTING. EACH MODE WAS TESTED FOR ABOUT TWO MINUTES EACH. THE TUBING POPPING OUT COULD NOT BE REPLICATED. THE GAS READING DROPPING TO YELLOW IS A WARNING TO THE USER (AN INDICATION) THAT THE GAS BOTTLE WILL SOON NEED TO BE REPLACED. THE GAS READING DROPS TO YELLOW WHEN THE BOTTLE GAS PRESSURE DROPS. THIS IS NORMAL. IN FACT THE GAS READING WILL DROP TO RED BEFORE THE GAS BOTTLE NEEDS TO BE REPLACED. ON 3/19/08: SPOKE TO SALES REP. ASKING ABOUT WHAT SETTING WERE USED WHEN TUBING POPPING OUT. HE MENTIONED THAT THE PRESSURE WAS SET AT 7MMHG WITH A FLOW SETTING OF 10 1/MIN. HE MENTIONED THE INSUFFLATOR WAS BEING USED FOR A PEDIATRIC CASE TO REMOVE A WASHER FROM THE PATIENT'S STOMACH. THE INSUFFLATOR WORKED FINE AND INSUFFLATED PROPERLY FOR THE FIRST HALF OF THE CASE. ABOUT 20 TO 25 MINUTES INTO THE CASE, THE TUBING POPPING OUT FROM THE UNIT AND THE RELEASED PRESSURE FROM THE PATIENT BELLY. WHEN ASKED, THE SALES REP. MENTIONED THAT THE TUBING WAS NOT EXPOSED TO ANY ABNORMAL EXTRA STRESS WHEN THE TUBING POPPED OUT. THE RELEASE OF PRESSURE CAUSED A LOT OF USER FRUSTRATION AND INCONVENIENCE. THE SURGEON THEN HAD TO CHANGE THE CASE PROCEDURE AND USED OPEN SURGEON TO REMOVE THE WASHER FROM THE STOMACH. THE CASE WAS PROLONGED BY 20 MINUTES. THE SALES REP. ALSO MENTIONED THAT HE TRIED REPLICATING THE POPPING OUT ISSUE AFTER THE CASE AND COULD NOT REPRODUCE THE TUBING POPPING OUT. THIS UNIT HAS BEEN USED FOR OTHER CASES AND HAD WORKED FINE. ON 3/20/08: THE UNIT WAS RETESTED USING THE SETTINGS USED DURING THE CASE BY MAUSAM PATEL, AND THE UNIT WAS RUN FOR ABOUT 45 MINUTES. THE UNIT WORKED FINE. UNABLE TO REPRODUCE THE TUBING POPPING OUT. IF THE TUBE SET IS PROPERLY LATCHED INTO THE CONSOLE, THEN IT IS DIFFICULT TO PULL THE TUBE SET OUT OF THE CONSOLE EVEN BY APPLYING DELIBERATE MANUAL PULL FORCE ON THE TUBE SET ADAPTOR TO REMOVE THE TUBE SET FROM THE CONSOLE. IN FACT BY DELIBERATING PULLING ON THE ADAPTOR, THE "TUBESET NOT CONNECTED" ERROR WOULD COME ON FIRST BEFORE THE LATCH WOULD DIS-ENGAGE. IF THE TUBE SET NOT CONNECTED ERROR COMES ON BUT THE TUBESET IS STILL LATCHED IN, THE INSUFFLATION WOULD STOP AND THE ERROR WOULD BE INDICATED ON THE SCREEN, BUT THE UNIT WOULD NOT RELEASE ANY PRESSURE. THE ONLY LIKELY CAUSE OF THE TUBE SET POPPING OUT DURING THE CASE IS THAT THE TUBE SET IS NOT PROPERLY LATCHED INTO THE CONSOLE WHEN THE CASE WAS STARTED AND HENCE THE TUBE SET POPPED OUT DURING THE CASE. WHEN THE TUBE SET IS CONNECTED THE FIRST CLICK SHOULD HAVE BEEN HEARD AND THE SCREEN SHOULD HAVE INDICATED THAT THE TUBESET IS CONNECTED. THEN THE USER MIGHT HAVE PUSHED THE TUBESET AGAIN TO ASSURE THAT THE TUBESET IS IN FACT PROPERLY CONNECTED. CLICKING THE TUBESET THE SECOND TIME WOULD DIS-LATCH THE TUBESET. BUT DUE TO THE O-RING PRESENT ON THE TUBESET ADAPTOR AND THE TUBESET BEING NEW, THE TUBESET WOULD NOT HAVE FALLEN OFF WHEN DIS-LATCHED AND THE TUBESET CONNECTOR SENSOR MIGHT HAVE STILL RECOGNIZED THE TUBESET AS THE TUBESET ADAPTOR WOULD STILL BE IN THE GROVE. THE CURRENT DESIGN IS SUCH THAT THE LATCH AND SENSOR ARE LOCATED ON T HE TOP AND BOTTOM OF THE ADAPTOR RESPECTIVELY. HENCE EVEN THOUGHT THE LATCH IS DISENGAGED FROM THE TOP, THE BOTTOM PART OF THE ADAPTOR MAY STILL BE HELD IN PLACE IN THE GROVE, DUE TO THE O-RING RESISTANCE. AS THE TUBESET WAS NOT LATCHED IN THIS HYPOTHETICAL SCENARIO, THE TUBESET CAN THEN POP OUT/FALL OFF AND RELEASE PRESSURE ANYTIME DURING THE CASE. CURRENTLY, WE ARE WORKING ON A NEW TUBE-SET SENSOR DESIGN WHERE AN OPTICAL SENSOR INSTEAD OF THE CURRENT MICRO-SWITCH SENSOR WOULD BE USED FOR BETTER PRECISION AND DETECTION ACCURACY. ALSO THE LOCATION OF THE OPTICAL SENSOR IS MADE TO BE AT THE SAME LOCATION. IN THE NEW DESIGN, THE SOFTWARE WILL BE CHANGED TO PROVIDE A BETTER GUI, WITH INDICATIONS OF WHEN THE TUBESET IS CONNECTED AND WHEN NOT. THE NEW DESIGN IS CURRENTLY IN THE TESTING PHASES. THIS DESIGN WOULD ADDRESS BOTH THE ABOVE SPECULATED PROBLEMS OF USER CONFUSION OF WHETHER THE TUBE SET IS CONNECTED OR NOT INDICATION AND ALSO PREVENT THE UNIT FROM STARTING INSUFFLATION IF THE TUBE-SET IS DISLATCHED. ROOT CAUSE: UNABLE TO REPRODUCE THE TUBING POPPING OUT. NO PROBLEM FOUND. RISK(S) OF THIS NATURE ARE EVALUATED IN RSK 446 REV. E. THE LISTED OCCURRENCE IS REMOTE AND SEVERITY IS SIGNIFICANT. AT THE TIME OF EVALUATING THIS COMPLAINT IT IS DETERMINED THAT TRENDING OF THIS RISK DOES NOT REQUIRE AN UPDATE TO THE OCCURRENCE.

    Description of Event or Problem · 1

    THE SALES REPRESENTATIVE REPORTED THAT WHILE VENTING DURING A PEDIATRIC CASE, THE TUBING POPPED OUT OF THE UNIT AND RELEASED PRESSURE. THE CASE HAD TO BE MODIFIED FROM A CLOSED PROCEDURE TO AN OPEN PROCEDURE DUE TO THE LACK OF INSUFFLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PNEUMO SURE HIGH FLOW INSUFFLATOR INSUFFLATOR FCX STRYKER ENDOSCOPY SAN JOSE 0710CE157

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention