BEUDAMED
    FDA Adverse Event Death Summary report: N

    AIRSEAL IFS, 110V

    MDR report key: 16446916 · Received February 27, 2023

    Report

    Report Number
    1320894-2023-00045
    Event Type
    Death
    Date Received
    February 27, 2023
    Date of Event
    February 1, 2023
    Report Date
    April 11, 2023
    Manufacturer
    W.O.M. WORLD OF MEDICINE GMBH
    Product Code
    HIF
    UDI-DI
    10851885004587
    PMA / PMN Number
    K190303
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OF ¿PATIENT DEVELOPED SUBCUTANEOUS EMPHYSEMA AND PASSED AWAY IN ICU¿ IS CONFIRMED. EVALUATION FOUND VENTING VALVE ERROR, OCCLUSION ERROR, VALVE/ COMPRESSOR ERROR, THE COMPRESSOR REQUIRED A REFURBISHMENT, LOW PRESSURE UNIT FAILURE AND THE DEVICE REQUIRED A SOFTWARE UPGRADE. ADDITIONALLY, THE PM WAS OVERDUE. PARTS WERE REPLACED, THE DEVICE REPAIRED AND THE PM PERFORMED; THE DEVICE WAS FINAL TESTED PER IP-800-031 AND MET ALL SPECIFICATIONS. THE SERVICE HISTORY WAS REVIEWED, AND NO RELATIONSHIP TO THIS COMPLAINT WAS FOUND. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD REVIEW WAS NOT PERFORMED AS THE DEVICE HAS BEEN IN THE FIELD MORE THAN 12 MONTHS. THE PRODUCT RELEASED FOR DISTRIBUTION WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: STRONG PRECAUTION TO AVOID INCORRECT PLACEMENT OF A CANNULA OR A TROCAR INTO SUBCUTANEOUS TISSUE. THIS MAY LEAD TO EMPHYSEMA. TO REDUCE THE RISK, USE A LOW GAS FLOW RATE FOR THE FIRST INSUFFLATION AND ENSURE THAT THE INSUFFLATION INSTRUMENT IS CORRECTLY POSITIONED. BE SURE TO CLOSE LEAKAGES IN TROCAR ACCESS POINTS IMMEDIATELY. THE USER IS ADVISED THAT THE MANUFACTURER STIPULATES THAT QUALIFIED PERSONNEL OR HOSPITAL TECHNICIANS MUST REGULARLY TEST THE DEVICE TO ASSESS ITS FUNCTIONALITY AND TECHNICAL SAFETY. THE DEVICE NEEDS TO BE SERVICED AT LEAST EVERY TWO YEARS. REGULAR INSPECTIONS WILL ASSIST IN THE EARLY DETECTION OF POSSIBLE MALFUNCTIONS. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS 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.

    Description of Event or Problem · 0

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE AS-IFS1, AIRSEAL IFS, 110V WAS USED DURING A ROBOTIC PROCEDURE W/ COLORECTAL & GYN SURGEONS ON THE DATE OF(B)(6) 2023 WHEN IT WAS REPORTED, ¿ SURGEONS WERE USING AIRSEAL IN A COMPLEX ROBOTIC PROCEDURE THAT LASTED ROUGHLY 8 HOURS. PATIENT ENDED UP GETTING SUBCUTANEOUS EMPHYSEMA EXTREMELY BAD. PATIENT ENDED UP PASSING AWAY.¿. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS SENT TO ICU. PER THE COMPLAINT, THE PATIENT IS DECEASED. FURTHER ASSESSMENT ANSWERS WERE REQUESTED OF THE REPORTER AND A GOOD FAITH EFFORT WAS COMPLETED; HOWEVER, THE REPORTER HAS NOT RESPONDED TO OUR ATTEMPTS FOR INFORMATION. THIS REPORT IS BEING RAISED ON THE BASIS OF DEATH DUE TO SUBCUTANEOUS EMPHYSEMA.

    Description of Event or Problem · 0

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE AS-IFS1, AIRSEAL IFS, 110V WAS USED DURING A ROBOTIC PROCEDURE W/ COLORECTAL & GYN SURGEONS ON THE DATE OF ON (B)(6) 2023 WHEN IT WAS REPORTED, ¿ SURGEONS WERE USING AIRSEAL IN A COMPLEX ROBOTIC PROCEDURE THAT LASTED ROUGHLY 8 HOURS. PATIENT ENDED UP GETTING SUBCUTANEOUS EMPHYSEMA EXTREMELY BAD. PATIENT ENDED UP PASSING AWAY.¿. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS SENT TO ICU. PER THE COMPLAINT, THE PATIENT IS DECEASED. FURTHER ASSESSMENT ANSWERS WERE REQUESTED OF THE REPORTER AND A GOOD FAITH EFFORT WAS COMPLETED; HOWEVER, THE REPORTER HAS NOT RESPONDED TO OUR ATTEMPTS FOR INFORMATION. THIS REPORT IS BEING RAISED ON THE BASIS OF DEATH DUE TO SUBCUTANEOUS EMPHYSEMA

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787418 AIRSEAL IFS, 110V INSUFFLATOR, LAPAROSCOPIC HIF W.O.M. WORLD OF MEDICINE GMBH 10851885004587

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death