BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRSEAL IFS, 110V

    MDR report key: 12907589 · Received December 1, 2021

    Report

    Report Number
    1320894-2021-00423
    Event Type
    Injury
    Date Received
    December 1, 2021
    Report Date
    December 1, 2021
    Manufacturer
    W.O.M WORLD OF MEDICINE GMBH
    Product Code
    HIF
    PMA / PMN Number
    K190303
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRODUCT CODE; GCJ MANUFACTURER NARRATIVE: REPORTED EVENT IS INCONCLUSIVE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AND NO PHOTOGRAPHIC EVIDENCE HAS BEEN PROVIDED; THEREFORE, THE REPORTED EVENT CANNOT BE VERIFIED. A SERVICE HISTORY CANNOT NOT BE CONDUCTED DUE TO THE UNAVAILABILITY OF THE SERIAL NUMBER. A DEVICE HISTORY REVIEW CANNOT NOT BE CONDUCTED AS NO SERIAL NUMBER WAS PROVIDED. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 7 COMPLAINTS, REGARDING 7 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME (B)(4) 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 (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: HIGHER INSUFFLATION PRESSURES (>15MM HG) OF CARBON DIOXIDE INSUFFLATION CAN INCREASE THE RISK OF HYPERCARBIA, SUBCUTANEOUS EMPHYSEMA, PNEUMOMEDIASTINUM, PNEUMOTHORAX, PNEUMOSCROTUM AND URINARY RETENTION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    THE CONMED (B)(4) REPORTED ON BEHALF OF THE CUSTOMER REPORTED THAT THE AS-IFS1, AIRSEAL IFS, 110V DEVICE WAS BEING USED DURING A LAPAROSCOPIC HEPATECTOMY PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED THAT ¿ABOUT ONE YEAR AGO, CO2 GAS EMBOLISM OCCURRED DURING LAPAROSCOPIC HEPATECTOMY USING AIRSEAL. SATURATION RAPIDLY DECREASED. INSUFFLATION WAS STOPPED. IT TOOK TIME FOR PATIENT'S RECOVERY (LONGER THAN A STANDARD INSUFFLATOR).¿ AFTER FURTHER ASSESSMENT IT WAS FOUND, THE PROCEDURE WAS CONVERTED TO OPEN BECAUSE CO2 GAS EMBOLISM OCCURRED. GAS FLOW SETTING WAS AIRSEAL MODE AND 8MMHG WAS USED. MEDICALLY PURE CO2 WAS USED. IT IS ALSO NOTED THAT NO DEVICE MALFUNCTION OCCURRED DURING THE REPORTED INCIDENT. IT WAS NOTED BY A SURGEON THAT "CO2 GAS EMBOLISM OCCURRED ALSO DURING OPEN SURGERY. THE RELATION BETWEEN IAP AND CVP MIGHT BE RELATED TO CO2 GAS EMBOLISM. HOWEVER, IF A PATIENT WOULD HAVE HEART DISEASE, THE EFFECT COULD WORK VISE-VERSA." THERE WAS A DELAY OF AN UNKNOWN AMOUNT OF TIME. THE PATIENT WAS DISCHARGED AND THERE WAS NO PROLONGED HOSPITALIZATION. THIS REPORT IS BEING RAISED ON THE BASIS INJURY OF DUE TO GAS EMBOLISM AND CONVERTING TO AN OPEN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1810292 AIRSEAL IFS, 110V INSUFFLATOR, LAPAROSCOPIC HIF W.O.M WORLD OF MEDICINE GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| O