BEUDAMED
    FDA Adverse Event Other Summary report: N

    SURGIQUEST AIRSEAL

    MDR report key: 3528194 · Received December 12, 2013

    Report

    Report Number
    3006217371-2013-00004
    Event Type
    Other
    Date Received
    December 12, 2013
    Date of Event
    October 1, 2013
    Report Date
    December 9, 2013
    Manufacturer
    SURGIQUEST, INC.
    Product Code
    HIF
    PMA / PMN Number
    K103692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY AND CONCLUSIONS: CO2 IS THE PREFERRED INSUFFLATION GAS USED IN MINIMALLY INVASIVE OR LAPAROSCOPIC SURGERY. THE PRESSURIZATION OF THE GAS IN TO THE SUBCUTANEOUS TISSUE IS COMMONLY REFERRED TO AS SUBCUTANEOUS EMPHYSEMA. SUBCUTANEOUS EMPHYSEMA FOLLOWING LAPAROSCOPIC PROCEDURES IS A WELL-RECOGNIZED RISK. THIS SPECIFIC EFFECT IS A KNOWN EFFECT IN ALL MINIMALLY INVASIVE SURGICAL PROCEDURES AND NOT UNIQUE TO SURGERY PERFORMED WITH THE AIRSEAL SYSTEM. THIS EFFECT, IN FACT, IS WELL KNOWN IN BOTH ROBOTIC SURGERY AND IN LAPAROSCOPIC SURGICAL PROCEDURES AND IS WIDELY REPORTED IN MANY PEER-REVIEWED PUBLICATIONS. MANY CASES OF SUBCUTANEOUS EMPHYSEMA GO UNREPORTED AS THE CONDITION IS TYPICALLY SUB-CLINICAL AND IS USUALLY OF NO LASTING NEGATIVE CONSEQUENCE. THE CONDITION TYPICALLY CLEARS ON ITS OWN WITH NO HARM OR SERIOUS INJURY DONE TO THE PT AND THEREFORE MANY INCIDENCES EITHER ARE NOT REPORTED BY THE SURGEON OR DO NOT RISE TO THE LEVEL OF A REPORTABLE EVENT IN ACCORDANCE WITH THE CFR [21 CFR PART 803]. IN THIS CASE, THE PT COMPLAINED OF POST-OPERATIVE PAIN AND IT IS REPORTED THAT THE HOSPITAL STAY WAS EXTENDED, SO THIS REPORTAGE IS BEING SUBMITTED UPON AWARENESS OF THE EVENT. ADDITIONALLY, THERE ARE MANY PUBLISHED KNOWN CAUSES AND CONTRIBUTING INDEPENDENT RISK FACTORS WITH REGARD TO SUBCUTANEOUS EMPHYSEMA. AMONG THE KNOWN CAUSES ARE USE OF A VERESS NEEDLE RESULTING IN ACCIDENTAL EXTRAPERITONEAL INSUFFLATION, PORT PLACEMENT WHERE THE PORT DOES NOT ACTUALLY EXTEND IN TO THE ABDOMEN AND THEREFORE PRESSURIZED GAS IS FORCED BETWEEN TISSUE LAYERS, UNINTENTIONAL "PULL-BACK" OF THE PORT DURING SURGERY CAUSING THE PRESSURIZED GAS TO BE FORCED INTO TISSUE LAYERS, THE NUMBER OF PORTS USED, ANGLE OF THE PORT INSERTION, REPEATED DISLODGING AND REINSERTION OF THE SURGICAL PORTS ENLARGING THE WOUND OR CREATING NEW TISSUE PATHS INTO WHICH THE GAS CAN FLOW, HIGHER INSUFFLATION PRESSURE SETTINGS, DURATION OF THE SURGERY, AGE OF THE PT, PT BMI (BODY MASS INDEX), AND PERITONEAL VS EXTRAPERITONEAL AND PREPERITONEAL SURGICAL PROCEDURES, BOTH OF THE LATTER WHICH CARRY A KNOWN HIGHER RISK. FINALLY AND IN CONCLUSION, THE PRESSURIZATION OF THE CO2 INTO THE SUBCUTANEOUS TISSUE IS A KNOWN RISK IN MINIMALLY INVASIVE SURGERY AND THIS CONDITION IS NOT UNIQUE TO THE SURGIQUEST AIRSEAL SYSTEM. THE SYSTEM HAS NOT BEEN RETURNED AND IT IS OUR UNDERSTANDING THAT THE IFS UNIT IS STILL IN USE. BASED ON WHAT WAS REPORTED TO THE COMPANY, THERE IS NO REASON TO BELIEVE THAT THERE WAS A DEVICE MALFUNCTION NOR WAS THERE DEATH OR SERIOUS INJURY TO THE PT IN ACCORDANCE WITH TERMS AND DEFINITIONS SET FORTH IN 21 CFR PART 803, "MEDICAL DEVICE REPORTING" AND FDA GUIDANCE. AGAIN, THE PT'S CONDITION CLEARED ON ITS OWN AND SHE WAS DISCHARGED W/O FURTHER INCIDENT. AGAIN, IN THIS CASE REPEATED ATTEMPTS HAVE BEEN MADE (EMAIL AND TELEPHONE) IN ORDER TO CONTACT THE SURGEON FOR ADD'L INFO REGARDING THE DETAILS OF THE CASE, I.E., INDEPENDENT RISK FACTORS ASSOCIATED WITH THE PT, INSUFFLATION PRESSURES USED, ETC. THESE ATTEMPTS HAVE BEEN MADE TO NO AVAIL. ADDITIONALLY, THE SURGEON HAS REFUSED THE COMPANY'S OFFER TO TRAVEL TO THE HOSPITAL TO MEET WITH HIM NOR WILL HE SPEAK ANY FURTHER WITH COMPANY REPS REGARDING THE REPORTED SCE. THEREFORE, WE HAVE ONLY A BRIEF E-MAIL DESCRIPTION OF THE CASE AND WHAT FACTS WERE ABLE TO BE GATHERED BY THE COMPANY REP ON SITE. THE COMPANY DOES NOT KNOW WHETHER OR NOT A USER FACILITY REPORT WILL BE FILED, BUT HAS TAKEN A PROACTIVE STANCE IN REPORTING TO FDA. THE COMPANY CONTINUES TO MONITOR THE CLINICAL USE OF AIRSEAL IN ACCORDANCE WITH THE STANDARDS AND WORKS DILIGENTLY TO IMPROVE PRODUCT SAFETY AND DESIGN AS PART OF OUR COMMITMENT TO CONTINUOUS IMPROVEMENT.

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED AFTER INITIATING E-MAIL COMMUNICATION WITH A SURGEON THAT A FEMALE PT, AFTER A LAPAROSCOPIC TOTAL HYSTERECTOMY SURGERY, PRESENTED WITH SUBCUTANEOUS EMPHYSEMA AND COMPLAINED OF PAIN IN THE ABDOMEN AND LEGS. THE PT STAY WAS PROLONGED THREE (3) DAYS AND THE PT WAS DISCHARGED W/O FURTHER INCIDENT. NO USER FACILITY REPORT HAS BEEN REC'D TO DATE. ON (B)(6) 2013, THE COMPANY BECAME AWARE OF A REPORT OF SUBCUTANEOUS EMPHYSEMA (SCE) USING THE SURGIQUEST AIRSEAL SYSTEM THROUGH EMAIL COMMUNICATION FROM THE SURGEON TO A COMPANY REP. THE SURGIQUEST AIRSEAL SYSTEM IS A LAPAROSCOPIC ACCESS SYSTEM USED TO CREATE A PATH OF ENTRY FOR MINIMALLY INVASIVE SURGERY AND IS CLEARED UNDER 510(K) [K103692]. IT WAS REPORTED THAT THE PT PRESENTED SCE IN THE ABDOMEN AND THE LEGS AFTER A LAPAROSCOPIC TOTAL HYSTERECTOMY. THE AIRSEAL BLUNT CANNULA WAS EMPLOYED AS A CAMERA PORT THROUGH THE UMBILICUS. PORTS WERE EXCHANGED DURING THE SURGICAL PROCEDURE. IT WAS REPORTED THAT THE PT COMPLAINED OF POST-OPERATIVE PAIN AND HOSPITAL STAY WAS EXTENDED FOR THREE DAYS. THERE WAS NO SERIOUS INJURY TO THE PT AS A RESULT OF THE PROCEDURE. IT IS OUR UNDERSTANDING THAT THE SYMPTOMS CLEARED UNEVENTFULLY AND THE PT WAS DISCHARGED WITHOUT FURTHER INCIDENT. REPEATED ATTEMPTS HAVE BEEN MADE (E-MAIL AND TELEPHONE) IN ORDER TO CONTACT THE SURGEON FOR ADD'L INFO REGARDING THE DETAILS OF THE CASE, I.E., INDEPENDENT RISK FACTORS ASSOCIATED WITH THE PT, INSUFFLATION PRESSURES USED, ETC. THE SURGEON RESPONDED TO ONE E-MAIL CORRESPONDENCE WHERE WE WERE SUCCESSFUL IN MAKING CONTACT BY INDICATING THAT HE WAS NOT INTERESTED IN DISCUSSING THE MATTER FURTHER. THE INCIDENT IN QUESTION OCCURRED APPROX THREE (3) WEEKS PRIOR TO THE E-MAIL COMMUNICATION OF THE SCE BEING RECEIVED, OR ON OR ABOUT (B)(6) 2013. NOTABLY, THE COMMUNICATION FROM THE SURGEON REGARDING THIS CASE WAS MADE ONLY IN RESPONSE TO AN E-MAIL SENT BY THE COMPANY REP INQUIRING ABOUT AN EVAL OF THE AIRSEAL TECHNOLOGY. NO USER FACILITY (UF) REPORT HAS BEEN RECEIVED AT THE TIME OF THIS REPORTAGE. THE AIRSEAL IFS DEVICE IN QUESTION WAS NOT RETURNED TO SURGIQUEST FOR EVAL NOR WERE ANY OF THE DISPOSABLE TROCARS USED IN PERFORMING THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651317 SURGIQUEST AIRSEAL INSUFFLATOR HIF SURGIQUEST, INC. AS-IFS1

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization CANNULA| LAPAROSCOPIC DISPOSABLE TROCAR