BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIQUEST AIRSEAL

    MDR report key: 4135280 · Received September 25, 2014

    Report

    Report Number
    3006217371-2014-00001
    Event Type
    Injury
    Date Received
    September 25, 2014
    Date of Event
    February 18, 2014
    Report Date
    August 26, 2014
    Manufacturer
    SURGIQUEST, INC.
    Product Code
    GCJ
    PMA / PMN Number
    K103692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGIQUEST AIRSEAL IFS SYSTEM IS A LAPAROSCOPIC ACCESS SYSTEM USED TO CREATE AND MAINTAIN A PATH OF ENTRY FOR MINIMALLY INVASIVE SURGERY AND IS CLEARED UNDER 510 (K) [K103692]. WHILE THERE IS A REPORT OF PNEUMOTHORAX, THERE IS NO CLEAR EVIDENCE THAT REASONABLY SUGGESTS THAT USE OF THE AIRSEAL IFS WAS IN ANY WAY THE CAUSE OF THE CONDITION; NOR WAS THERE A CLAIM BY THE SURGEON THAT THE DEVICE WAS THE CAUSE. WHILE THERE IS NO EVIDENCE TO SUGGEST THAT AIRSEAL IFS CAUSED THIS EVENT, THE COMPANY IS SUBMITTING THIS REPORT IN ACCORDANCE WITH 21 CFR PART 803. LAPAROSCOPIC PROCEDURES HAVE LONG BEEN ASSOCIATED WITH THORACIC COMPLICATIONS INCLUDING PNEUMOTHORAX. PUBLISHED LITERATURE ON THE INCIDENCE OF PNEUMOTHORAX IS QUIRE VOLUMINOUS AND CONCLUDES THAT THERE ARE MANY AND VARIOUS REASONS WHY THIS CONDITION PRESENTS DURING OR FOLLOWING LAPAROSCOPIC SURGICAL PROCEDURES; PARTICULARLY, IN HIGHER RISK PATIENTS AND IN ANATOMICAL REGIONS WHERE THER IS A HIGH RISK OF VIOLATION OF ANATOMICAL SPACES PRONE TO CAUSE MIGRATION OF GAS INTO THE THORACIC CAVITY. IN THIS CASE, THE PT WAS (B)(6) THUS QUALIFYING THE PT AS HIGHER RISK BASED ON PUBLISHED LITERATURE. ADDITIONALLY, A PERITONEAL PRESSURE OF 15 MMHG WAS EMPLOYED DURING THE PROCEDURE AND THE LENGTH OF THE PROCEDURE WAS 4.5 HRS. FURTHERMORE, MULTIPLE TROCARS WERE USED IN THIS ADVANCED LAPAROSCOPIC CASE AND THE TECHNIQUE REQUIRED THE PLACEMENT OF OTHER MEDICAL DEVICES CLOSE TO THE DIAPHRAGM. HIGHER INSUFFLATION PRESSURES COMBINED WITH DEVICES IN PROXIMITY TO THE DIAPHRAGM INCREASE THE POTENTIAL FOR CREATING A RENT OR DEFECT IN THE PERITONEAL BARRIER THUS MAKING THE REPORTED CONDITION MORE LIKELY TO OCCUR. WHILE THE ROOT CAUSE IS UNK, IN LIGHT OF THE RISK FACTORS, THE SURGICAL PROCEDURE, LENGTH AND TECHNIQUE, WE BELIEVE THAT IT IS HIGHLY UNLIKELY THAT THE USE OF THE AIRSEAL IFS WAS THE CAUSE OF THE POST-OPERATIVE CONDITION, BUT CANNOT SUBSTANTIATE OTHERWISE. THE SYSTEM HAS BEEN EMPLOYED IN APPROXIMATELY 200,000 SURGERIES TO DATE AND THERE HAVE BEEN NO REPORTABLE INCIDENTS RELATED TO ITS USE AND THE CREATION OF THIS CONDITION. WHILE IT APPEARS UNLIKELY THAT A USER FACILITY REPORT WILL BE FILED, THE COMPANY HAS TAKEN A PROACTIVE STANCE IN REPORTING TO FDA. THE COMPANY CONTINUES TO MONITOR THE CLINICAL USE OF AIRSEAL IN ACCORDANCE WITH COMPANY POLICY AND PROCEDURES AND WORKS DILIGENTLY TO IMPROVE PRODUCT SAFETY AND DESIGN AS A PART OF THE COMPANY'S COMMITMENT TO CONTINUOUS IMPROVEMENT.

    Description of Event or Problem · 1

    THE COMPANY WAS MADE AWARE ON (B)(6) 2014 THAT A PT AT (B)(6), RETURNED TO THE HOSP SOME WEEKS AFTER UNDERGOING TRANSPERITONEAL PARTIAL NEPHRECTOMY AND WAS DIAGNOSED WITH A BRONCHIAL INFECTION. UPON CHEST X-RAY, PNEUMOTHORAX WAS DETECTED. THE PT WAS READMITTED AND A CHEST TUBE WAS INSERTED IN ORDER TO RESOLVE THE PNEUMOTHORAX. THE CONDITION RESOLVED WITHOUT FURTHER INCIDENT. THE EVENT OCCURRED ON (B)(6) 2014 PRECEDING THE REPORT AND AWARENESS DATE BY MORE THAN 6 MONTHS AND WAS NOT REPORTED AT THE TIME. THE DEVICE IN QUESTION IS STILL IN USE AT THE FACILITY. NO USER FACILITY REPORT HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599481 SURGIQUEST AIRSEAL INSUFFLATOR GCJ SURGIQUEST, INC. AS-IFS1

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization