BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRSEAL IFS, 110V

    MDR report key: 13255318 · Received January 13, 2022

    Report

    Report Number
    1320894-2022-00017
    Event Type
    Injury
    Date Received
    January 13, 2022
    Report Date
    March 18, 2022
    Manufacturer
    W.O.M. WORLD OF MEDICINE GMBH
    Product Code
    HIF
    PMA / PMN Number
    K190303
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL FDA PRODUCT CODE: GCJ THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION AND REVIEW. HOWEVER, THE COMPLAINT INVESTIGATION IS NOT COMPLETE AT THIS TIME. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE COMPLAINT INVESTIGATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 0

    MANUFACTURER NARRATIVE: REPORTED EVENT IS INCONCLUSIVE. THE DEVICE IS NOT BEING RETURNED AND NO PHOTOGRAPHIC EVIDENCE WAS PROVIDED. THEREFORE, THE REPORTED FAILURE COULD NOT BE VERIFIED. THE SERVICE HISTORY COULD NOT BE PERFORMED SINCE A SERIAL NUMBER WAS NOT PROVIDED. A REVIEW OF THE DEVICE HISTORY REVIEW COULD NOT BE PERFORMED SINCE A SERIAL NUMBER WAS NOT PROVIDED. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 15 REPORTS, REGARDING (B)(6) DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME (B)(6) DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED FOR THIS REPORTED FAILURE, THE RATE OF FAILURE WOULD BE 0.006. PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: IMPROPER PLACEMENT OF THE INSUFFLATION INSTRUMENT COULD CAUSE GAS PENETRATING A VESSEL OR AN INTERNAL ORGAN, RESULTING IN GAS EMBOLISM. TO REDUCE THE RISK, USE A LOW FLOW RATE FOR THE FIRST INSUFFLATION AND ENSURE THAT THE INSUFFLATION INSTRUMENT IS CORRECTLY POSITIONED. CHECK THE POSITION OF THE INSUFFLATION INSTRUMENT IMMEDIATELY IF THE ACTUAL PRESSURE RAPIDLY REACHES THE NOMINAL PRESSURE VALUE. GAS EMBOLISM CAN ALSO BE CAUSED BY A HIGH INTRA-ABDOMINAL PRESSURE. AVOID HIGH-PRESSURE SETTINGS AND CLOSE DAMAGED BLOOD VESSELS AT ONCE. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    THIS COMPLAINT WAS CREATED DUE TO A CONMED (B)(4) EMPLOYEE READING AN UNKNOWN PUBLIC SCIENTIFIC ARTICLE ON 14DEC21 REGARDING THE DEVICE, AS-IFS1,AIRSEAL IFS, 110V. SPECIFIC EVENTS WERE NOT DISCLOSED; HOWEVER, THE EVENTS HAD OCCURRED BETWEEN THE TIMEFRAME OF 2009 TO 2018. NO INFORMATION IS KNOWN ON THE STATUS OF THE PATIENTS. AND NO INDICATION OF ANY CONMED DEVICE MALFUNCTION WAS REPORTED. THE ARTICLE REPORTS THAT ¿CLOSE EXAMINATION OF POSTOPERATIVE COMPLICATIONS IN 57 RLR CASES REVEALED THAT SIX OF THE SEVEN MAJOR EVENTS (86%) WERE SYSTEMIC COMPLICATIONS, AND MOST OF THESE WERE CONSIDERED RELATED TO THE AIRSEAL SYSTEM. IN THESE CASES, GRAVE CO2 GAS EMBOLISM WITH SIGNIFICANT HYPOTENSION WAS OBSERVED, EVEN WITH MINOR HV INJURIES; THIS SOMETIMES OCCURRED WITHOUT SIGNIFICANT GAS EMBOLISM DURING LLR OR EVEN RLR USING A CONVENTIONAL PNEUMOPERITONEAL MACHINE. FURTHERMORE, NO SYSTEMIC COMPLICATIONS OCCURRED AFTER DISCONTINUING THE USE OF THE AIRSEAL SYSTEM. THESE FINDINGS AND THE MECHANICAL ACTIONS OF THE AIRSEAL SYSTEM COLLECTIVELY IMPLY THAT WE SHOULD AVOID USING THIS SYSTEM, PARTICULARLY DURING AR, WHERE THE MAJOR HVS ARE ROUTINELY EXPOSED DURING PARENCHYMAL DISSECTION. THE AIRSEAL SYSTEM-RELATED SEVERE COMPLICATIONS ARE NOT LIMITED TO RLR.¿ THIS REPORT IS BEING RAISE ON THE BASIS OF INJURY DUE TO REPORT OF CO2 GAS EMBOLISM WITH SIGNIFICANT HYPOTENSION.

    Description of Event or Problem · 0

    UPDATE: THE ARTICLE THIS COMPLAINT IS CREATED FROM IS ¿HEPATOMA RESEARCH¿ HTTPS://WWW.HRJOURNAL.NET/. A CONMED EMPLOYEE ATTENDED THE ANNUAL MEETING OF THE JAPAN SOCIETY FOR ENDOSCOPIC SURGERY AND LISTENED TO THE AUTHOR¿S SESSION. THIS COMPLAINT WAS CREATED DUE TO A CONMED JAPAN EMPLOYEE READING AN UNKNOWN PUBLIC SCIENTIFIC ARTICLE ON 14DEC21 REGARDING THE DEVICE, AS-IFS1,AIRSEAL IFS, 110V. SPECIFIC EVENTS WERE NOT DISCLOSED; HOWEVER, THE EVENTS HAD OCCURRED BETWEEN THE TIMEFRAME OF 2009 TO 2018. NO INFORMATION IS KNOWN ON THE STATUS OF THE PATIENTS. AND NO INDICATION OF ANY CONMED DEVICE MALFUNCTION WAS REPORTED. THE ARTICLE REPORTS THAT ¿CLOSE EXAMINATION OF POSTOPERATIVE COMPLICATIONS IN 57 RLR CASES REVEALED THAT SIX OF THE SEVEN MAJOR EVENTS (86%) WERE SYSTEMIC COMPLICATIONS, AND MOST OF THESE WERE CONSIDERED RELATED TO THE AIRSEAL SYSTEM. IN THESE CASES, GRAVE CO2 GAS EMBOLISM WITH SIGNIFICANT HYPOTENSION WAS OBSERVED, EVEN WITH MINOR HV INJURIES; THIS SOMETIMES OCCURRED WITHOUT SIGNIFICANT GAS EMBOLISM DURING LLR OR EVEN RLR USING A CONVENTIONAL PNEUMOPERITONEAL MACHINE. FURTHERMORE, NO SYSTEMIC COMPLICATIONS OCCURRED AFTER DISCONTINUING THE USE OF THE AIRSEAL SYSTEM. THESE FINDINGS AND THE MECHANICAL ACTIONS OF THE AIRSEAL SYSTEM COLLECTIVELY IMPLY THAT WE SHOULD AVOID USING THIS SYSTEM, PARTICULARLY DURING AR, WHERE THE MAJOR HVS ARE ROUTINELY EXPOSED DURING PARENCHYMAL DISSECTION. THE AIRSEAL SYSTEM-RELATED SEVERE COMPLICATIONS ARE NOT LIMITED TO RLR.¿ THIS REPORT IS BEING RAISE ON THE BASIS OF INJURY DUE TO REPORT OF CO2 GAS EMBOLISM WITH SIGNIFICANT HYPOTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1018332 AIRSEAL IFS, 110V INSUFFLATOR, LAPAROSCOPIC HIF W.O.M. WORLD OF MEDICINE GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other