BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEBULAE I

    MDR report key: 12840684 · Received November 18, 2021

    Report

    Report Number
    0001450997-2021-00009
    Event Type
    Malfunction
    Date Received
    November 18, 2021
    Date of Event
    September 14, 2021
    Report Date
    October 7, 2021
    Manufacturer
    NORTHGATE TECHNOLOGIES, INC
    Product Code
    HIF
    UDI-DI
    00817183020189
    PMA / PMN Number
    K120151
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSUFFLATOR, NTI PART NUMBER 7-650-00; (B)(4) WAS RETURNED TO NORTHGATE TECHNOLOGIES, INC ON 10/19/2021 FROM THE DISTRIBUTOR (B)(4). THE UNIT WAS INSPECTED BY SERVICE STARTING ON 10/29/2021 FOR THE ALLEGED ISSUE. THE DEVICE WAS FURTHER INVESTIGATED UNDER CAPA (B)(4). PER THE CAPA (B)(4) INVESTIGATION, IT WAS IDENTIFIED THAT BOTH OF THE ELECTRONIC PRESSURE RELIEF VALVES (EPRVS) ACTIVATED APPROPRIATELY HOWEVER THEY DID NOT OPEN FULLY TO REDUCE THE PRESSURE WITHIN THE SPECIFIED TIME FRAME (WITHIN SPECIFICATION). THE MECHANICAL RELIEF VALVE DID OPERATE WITHIN SPECIFICATION. A SPECIFIC ROOT CAUSE FOR THE OVERPRESSURE CONDITION COULD NOT BE DETERMINED AT THIS TIME, HOWEVER THE INVESTIGATION LEADS US TO BELIEVE THAT ISSUE MAY HAVE BEEN RELATED TO A RESTRICTION WHICH WOULD CAUSE THE DEVICE TO INCREASE THE FLOW RATE AND THEN THE IDENTIFIED FAILURE OF BOTH ELECTRONIC PRESSURE RELIEF VALVES TO NOT VENT FAST ENOUGH WOULD HAVE CONTRIBUTED TO THE LENGTH OF TIME THE OVER PRESSURE SITUATION WAS MAINTAINED / OBSERVED. A CONTRIBUTING FACTOR IS THAT THE FLOW RATE OF THE DEVICE WAS MEASURED AT THE HIGH END OF THE ACCEPTABLE RANGE OR SLIGHTLY OVER THE ACCEPTABLE RANGE. THIS IS NOT BELIEVED TO BE THE ROOT CAUSE BUT COULD HAVE CONTRIBUTED TO THE ISSUE. THE DEVICE HISTORY RECORD FOR (B)(4) FROM NOVEMBER OF 2018 (MANUFACTURING ORDER (B)(4)) WAS REVIEWED AND THE DEVICE PASSED ALL TESTING. NOTHING OUT OF THE ORDINARY WAS NOTED. THE DEVICE HAS NOT BEEN RETURNED TO NTI FOR REPAIR / EVALUATION PREVIOUSLY. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED TO NTI FOR THIS DEVICE. A CAUTION IN THE MANUAL RECOMMENDS YEARLY MAINTENANCE AND CALIBRATION OF THE UNIT. THIS EVENT IS BEING REPORTED AS A DEVICE MALFUNCTION PER 21 CFR 803 GIVEN THAT THERE WERE NO SERIOUS INJURIES OR ADVERSE EVENTS REPORTED BUT THE EVALUATION AS FOUND REASONABLY SUGGESTS THAT THE DEVICE MALFUNCTIONED AND THAT THE DEVICE OR A SIMILAR DEVICE MARKETED BY THE MANUFACTURER COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH IF THE MALFUNCTION WERE TO RECUR DEPENDING ON THE LOCATION OF THE MALFUNCTION AND OTHER CONTRIBUTING FACTORS. (B)(4) RISK ANALYSIS WAS REVIEWED. SECTION 7.8.1.10.1 (A) REFERS TO THE RISK OF PRESSURE IN GENERAL LAPAROSCOPIC MODE WHICH RESULTS IN CO2 ABSORPTION (INTRAVASATION), HYPERCAPNIA , SUBCUTANEOUS EMPHYSEMA. THE MITIGATION OF THE RISK IS WARNING IN MANUAL (A,B.C,D) ON DANGERS OF CO2 ABSORPTION, EMBOLISM, IDIOSYNCRATIC REACTIONS, METABOLIC AND CARDIAC REACTIONS; THE DANGER OF SUBCUTANEOUS EMPHYSEMA. ADDITIONAL DEVICE MITIGATIONS: THE OVERSHOOT IS LIMITED TO FDA RECOMMENDATION NOT TO EXCEED 45 MMHG FOR MORE THAN 15 SECONDS; THE OVERPRESSURE ALERT WILL ACTIVATE AT 5 MMHG 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; AND VISUAL AND AUDIBLE INDICATORS ARE ON THE MACHINE TO INDICATE VOLUME OF GAS REMAINING IN CYLINDER. A CLINICAL EVALUATION WAS PERFORMED PER (B)(4) WHICH PROVED THE BENEFITS OUTWEIGH THE RISKS. SECTION 7.8.4.2 REFERS TO THE RISK OF THE DEVICE NOT BEING MAINTAINED / SERVICED ON AN ANNUAL BASIS. THE MANUAL CONTAINS A CAUTION RECOMMENDING ANNUAL EVALUATION AND CALIBRATION. LINE ITEM 7.6.4 DISCUSSES LOSS OF MECHANICAL INTEGRITY CAUSING THE DEVICE TO NOT PERFORM TO SPECIFICATION DUE TO MECHANICAL DEGRADATION WITH AGE. THE MITIGATION OF RISK IS THAT AN FMEA ((B)(4)) WAS DEVELOPED TO IDENTIFY ANY RISKS DUE TO FAILURE AND A CAUTION IS IN MANUAL RECOMMENDING YEARLY MAINTENANCE AND CALIBRATION OF THE UNIT. THE RISK CATEGORY POST MITIGATION IS ACCEPTABLE. A CLINICAL EVALUATION WAS PERFORMED PER (B)(4) WHICH PROVED THE BENEFITS OUTWEIGH THE RISKS. IF ANY FURTHER INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON (B)(6) 2021 NORTHGATE TECHNOLOGIES, INC WAS MADE AWARE OF THE ALLEGED EVENT, "RIGHT AFTER THE FIRST INSUFFLATION (NO OTHER TROCAR WAS INSERTED YET), THE UNIT INSUFFLATED TOO MUCH AND THE PATIENT'S BODY WAS GETTING PUMPED UP (PNEUMO WAS SOLID AS A ROCK).- THERE IS NO HEALTH INJURY.- MESENTERY SURGERY.- NOT REPEATABLE AT (B)(4) ACTION: REBOOTED-UP THE UNIT AND RESTARTED THE SURGERY AT 5LPM, 10MMHG. THERE WAS NO PROBLEM AFTER THAT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1738170 NEBULAE I LAPAROSCOPIC INSUFFLATOR HIF NORTHGATE TECHNOLOGIES, INC 7-650-00 00817183020189

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention