NEBULAE I
Report
- Report Number
- 0001450997-2024-00008
- Event Type
- Malfunction
- Date Received
- November 27, 2024
- Date of Event
- October 28, 2024
- Report Date
- December 19, 2024
- Manufacturer
- NORTHGATE TECHNOLOGIES INC.
- Product Code
- HIF
- PMA / PMN Number
- K120151
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
ON 10/31/2024, NORTHGATE TECHNOLOGIES WAS MADE AWARE OF THE FOLLOWING ALLEGED ISSUE FROM A JAPANESE DISTRIBUTOR "THE INSUFFLATION DID NOT STOP AND THE PATIENT'S STOMACH LOOKED BLOATED. THE SURGEON TOOK THE AIR OUT FROM A PORT IMMEDIATELY. OUR ENGINEER CHECKED THE UNIT, BUT NO DEFECT WAS FOUND." THE DEVICE WAS RECEIVED ON 11/25/24 BUT HAS NOT BEEN EVALUATED YET. THE DEVICE HISTORY RECORD FOR #90454EZB FROM APRIL OF 2015 (MO11825) WAS REVIEWED AND THE DEVICE PASSED ALL TESTING. NOTHING OUT OF THE ORDINARY WAS NOTED. THE DEVICE WAS RETURNED TO NTI VIA RMA 29725 (10/2015) WITH A COMPLAINT OF " THERE WAS NO PRESSURE ON THE PATIENTS ABDOMEN. THERE WAS NO RESTRICTION IN THE TUBING. ADDITIONAL INFORMATION IS THAT THE ERROR OCCURRED AFTER THORACIC CAVITY LAVAGE". COMPLAINT WAS NOT VERIFIED, THE DEVICE PERFORMED AS INTENDED, HOWEVER FC:11 WAS SAVED IN THE DEVICE MEMORY, BUT IT WAS UNABLE TO BE REPRODUCED. TO ENSURE THAT NO ISSUE IS MISSED THE VALVE CONTROLLER BOARD AND ELECTRONIC PRESSURE RELIEF VALVES WERE REPLACED WITH NEW PARTS, THE UNIT RECALIBRATED AND PASSED ALL FQC TESTING. THERE HAVE BEEN NO OTHER COMPLAINTS OR SERVICE ON THIS DEVICE AT NTI SINCE 10/2015. NOR-DOC-DRA-0020 RISK ANALYSIS WAS REVIEWED. RISK ID 7.8.1.10 REFERS TO THE RISK OF PRESSURES ASSOCIATED WITH THE UNIT AND RISK TO THE PATIENT. THE RISK OF THOSE ITEMS RELATED TO HIGH PRESSURE (E.G., CO2 ABSORPTION (INTRAVASATION), HYPERCAPNIA, SUBCUTANEOUS EMPHYSEMA, PATIENTS EXPOSED TO HIGH PRESSURE, ETC.). THESE RISKS HAVE BEEN MITIGATED AS FOLLOWS: WARNING IN MANUAL ON DANGERS OF CO2 ABSORPTION, EMBOLISM, IDIOSYNCRATIC REACTIONS, METABOLIC AND CARDIAC REACTIONISM OVERSHOOT IS LIMITED TO FDA RECOMMENDATION NOT TO EXCEED 45MMHG FOR MORE THAN 15 SECONDS., OVERPRESSURE ALERT WILL ACTIVATE AT 5MMHG OVER THE PRESET AND A LAPSE OF LESS THAN OR EQUAL TO 5 SECONDS., MULTIPLE FAILURES ARE REQUIRED TO CAUSE OVERPRESSURE OF ABDOMINAL CAVITY. TEMPORARY DISABLING OF THE OVERPRESSURE ALERT WILL NOT EXCEED 30 SECONDS. IF THE DEVICE WERE TO BE DISPLAYING A HIGHER PRESSURE THAN ACTUAL THAT COULD BE A LOSS OF PNEUMO IF THE END USER REDUCED THE FLOW IN AN ATTEMPT TO BRING DOWN THE PRESSURE. A CLINICAL EVALUATION WAS PERFORMED PER NOR-DOC-CER-0001 WHICH PROVED THE BENEFITS OUTWEIGH THE RISKS. THIS DEVICE IS ALMOST 10 YEARS OLD; THE EXPECTED LIFETIME OF THE DEVICE IS 6 YEARS. THERE IS A CAUTION IN THE MANUAL RECOMMENDING YEARLY MAINTENANCE AND CALIBRATION OF THE UNIT. THIS UNIT HAS NOT BEEN RETURNED TO NTI FOR MAINTENANCE OR CALIBRATION SINCE 2015. THE DEVICE WAS RECEIVED AT NTI ON 11/25/2024. THE DEVICE EVALUATION DID NOT FIND ANY MALFUNCTIONS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE COMPLAINT REPORTED OF DEVICE DID NOT STOP INSUFFLATION AND BLOATED STOMACH. THE PRESSURE SENSING AND VENTING SAFETY FEATURES IN THE DEVICE WERE TESTED AND OPERATED AS DESIGNED. THE ITEMS NOTED DURING SERVICE (E.G., FAULT CODE 14, LOW FLOWS, AND DAMAGED CARD READER PINS) WOULD NOT HAVE CAUSED OR CONTRIBUTED TO THE COMPLAINT EVENT. THE INSUFFLATOR HAS 2 MAIN SAFETY MECHANISMS THE FIRST IS THE ELECTRONIC (SOFTWARE) CONTROLLED PRESSURE RELIEF MECHANISM WHICH WAS DESIGNED TO ENSURE PRESSURE RELIEF AT MAX PRESSURE OR WHEN PATIENT PRESSURE EXCEEDS SET PRESSURE BY MORE THAN 3 MMHG FOR MORE THAN 5 SEC. THIS IS WHAT IS REFERRED TO IN THE OPERATOR'S MANUAL AND IS DEPENDENT UPON THE SET PRESSURE OF THE DEVICE AND THE MAGNITUDE AND DURATION OF THE OVER PRESSURE CONDITION. THE SECOND SAFETY MECHANISM IS A MECHANICAL PRESSURE RELIEF VALVE THAT IS INTENDED TO ENSURE THAT PRESSURE OVERSHOOT DOES NOT EXCEED 45 MMHG FOR MORE THAN 15 SECONDS WHEN ESTABLISHING PNEUMOPERITONEUM. THESE WERE OPERATING AS DESIGNED AND INTENDED WHEN TESTED. NOR-DOC-DRA-0020 RISK ANALYSIS WAS REVIEWED. SECTION 7.8.6.7 REFERS TO DEVICE FAULT CODES STATING THAT, "FAULT CODES RESULT FROM SOFTWARE DETECTION OF HARDWARE PROBLEMS SUCH AS THE LOSS OF CALIBRATION DATA DUE TO A MEMORY PROBLEM. FAULT CODES TYPICALLY PROTECT THE USER AND PATIENT FROM HARM BUT MAY RESULT IN THE DELAY OF A PROCEDURE. THE SEVERITY IS A 2 (SIGNIFICANT DISCOMFORT OR PAIN, NO PERMANENT IMPAIRMENT) WHICH IS A LOW RISK. CLINICAL EVALUATION NOR-DOC-CER-0001 STATES THAT THE BENEFITS OUTWEIGH THE RISK. THE RISK OF DEATH OR SERIOUS INJURY FROM THE STATED ISSUE IS REMOTE. SECTION 7.8.3.2 B. REFERS TO INADEQUATE SUPPLY OF POWER OR COOLANT CAN LEAD TO PROCEDURAL DELAYS DUE TO LACK OF INSUFFLATION CAUSING LOSS OF PNEUMOPERITONEUM. THE SEVERITY IS A 3, THE LIKELIHOOD IS A 2, WHICH RESULTS IN A RISK LEVEL OF AN "A" WHICH CORRESPONDS TO ADDITIONAL ACTION IS REQUIRED. THE MANUAL CONTAINS A WARNING THAT THE UNIT BE CHECKED TO SEE IF IT IS POWERED AND OPERATING PROPERLY UPON LOSING PNEUMOPERITONEUM. THE RISK OF LOSS OF PNEUMO AND/OR A DELAY IN THE PROCEDURE WERE DEEMED ACCEPTABLE RISKS. A CLINICAL EVALUATION WAS PERFORMED PER NOR-DOC-CER-0001 WHICH PROVED THE BENEFITS OUTWEIGH THE RISKS.
ON 10/31/2024, NORTHGATE TECHNOLOGIES WAS MADE AWARE OF THE FOLLOWING ALLEGED ISSUE FROM A JAPANESE DISTRIBUTOR "THE INSUFFLATION DID NOT STOP AND THE PATIENT'S STOMACH LOOKED BLOATED. THE SURGEON TOOK THE AIR OUT FROM A PORT IMMEDIATELY. OUR ENGINEER CHECKED THE UNIT, BUT NO DEFECT WAS FOUND." THE DEVICE WAS RECEIVED ON 11/25/24 BUT HAS NOT BEEN EVALUATED YET. THE DEVICE HISTORY RECORD FOR # 90454EZB FROM APRIL OF 2015 (MO11825) WAS REVIEWED AND THE DEVICE PASSED ALL TESTING. NOTHING OUT OF THE ORDINARY WAS NOTED. THE DEVICE WAS RETURNED TO NTI VIA RMA 29725 (10/2015) WITH A COMPLAINT OF " THERE WAS NO PRESSURE ON THE PATIENTS ABDOMEN. THERE WAS NO RESTRICTION IN THE TUBING. ADDITIONAL INFORMATION IS THAT THE ERROR OCCURRED AFTER THORACIC CAVITY LAVAGE". COMPLAINT WAS NOT VERIFIED, THE DEVICE PERFORMED AS INTENDED, HOWEVER FC:11 WAS SAVED IN THE DEVICE MEMORY, BUT IT WAS UNABLE TO BE REPRODUCED. TO ENSURE THAT NO ISSUE IS MISSED THE VALVE CONTROLLER BOARD AND ELECTRONIC PRESSURE RELIEF VALVES WERE REPLACED WITH NEW PARTS, THE UNIT RECALIBRATED AND PASSED ALL FQC TESTING. THERE HAVE BEEN NO OTHER COMPLAINTS OR SERVICE ON THIS DEVICE AT NTI SINCE 10/2015. NOR-DOC-DRA-0020 RISK ANALYSIS WAS REVIEWED. RISK ID 7.8.1.10 REFERS TO THE RISK OF PRESSURES ASSOCIATED WITH THE UNIT AND RISK TO THE PATIENT. THE RISK OF THOSE ITEMS RELATED TO HIGH PRESSURE (E.G., CO2 ABSORPTION (INTRAVASATION), HYPERCAPNIA, SUBCUTANEOUS EMPHYSEMA, PATIENTS EXPOSED TO HIGH PRESSURE, ETC.). THESE RISKS HAVE BEEN MITIGATED AS FOLLOWS: WARNING IN MANUAL ON DANGERS OF CO2 ABSORPTION, EMBOLISM, IDIOSYNCRATIC REACTIONS, METABOLIC AND CARDIAC REACTIONISM OVERSHOOT IS LIMITED TO FDA RECOMMENDATION NOT TO EXCEED 45MMHG FOR MORE THAN 15 SECONDS., OVERPRESSURE ALERT WILL ACTIVATE AT 5MMHG OVER THE PRESET AND A LAPSE OF LESS THAN OR EQUAL TO 5 SECONDS., MULTIPLE FAILURES ARE REQUIRED TO CAUSE OVERPRESSURE OF ABDOMINAL CAVITY. TEMPORARY DISABLING OF THE OVERPRESSURE ALERT WILL NOT EXCEED 30 SECONDS. IF THE DEVICE WERE TO BE DISPLAYING A HIGHER PRESSURE THAN ACTUAL THAT COULD BE A LOSS OF PNEUMO IF THE END USER REDUCED THE FLOW IN AN ATTEMPT TO BRING DOWN THE PRESSURE. A CLINICAL EVALUATION WAS PERFORMED PER NOR-DOC-CER-0001 WHICH PROVED THE BENEFITS OUTWEIGH THE RISKS. THIS DEVICE IS ALMOST 10 YEARS OLD, THE EXPECTED LIFETIME OF THE DEVICE IS 6 YEARS. THERE IS A CAUTION IN THE MANUAL RECOMMENDING YEARLY MAINTENANCE AND CALIBRATION OF THE UNIT. THIS UNIT HAS NOT BEEN RETURNED TO NTI FOR MAINTENANCE OR CALIBRATION SINCE 2015. THE REPORTED DEVICE WAS RETURNED FOR EVALUATION AND RECEIVED ON 11/25/24. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.
ON 10/31/2024, NORTHGATE TECHNOLOGIES WAS MADE AWARE OF THE FOLLOWING ALLEGED EVENT FROM A DISTRIBUTOR LOCATED IN JAPAN, "THE INSUFFLATION DID NOT STOP AND THE PATIENT'S STOMACH LOOKED BLOATED. THE SURGEON TOOK THE AIR OUT FROM A PORT IMMEDIATELY. OUR ENGINEER CHECKED THE UNIT, BUT NO DEFECT WAS FOUND.". THE DEVICE WAS RETURNED TO THE MFG ON 11/25/27, EVALUATION IS IN PROCESS.
ON 10/31/2024, NORTHGATE TECHNOLOGIES WAS MADE AWARE OF THE FOLLOWING ALLEGED EVENT FROM A DISTRIBUTOR LOCATED IN JAPAN, "THE INSUFFLATION DID NOT STOP AND THE PATIENT'S STOMACH LOOKED BLOATED. THE SURGEON TOOK THE AIR OUT FROM A PORT IMMEDIATELY. OUR ENGINEER CHECKED THE UNIT, BUT NO DEFECT WAS FOUND.". THE DEVICE WAS RETURNED TO THE MFG ON 11/25/27, EVALUATION IS IN PROCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2356981 | NEBULAE I | LAPAROSCOPIC INSUFFLATOR | HIF | NORTHGATE TECHNOLOGIES INC. | 7-650-00 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |