BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRSEAL IFS, 110V

    MDR report key: 12907610 · Received December 1, 2021

    Report

    Report Number
    1320894-2021-00424
    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
    OTHER

    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

    CONMED JAPAN REPORTED ON BEHALF OF THE CUSTOMER REPORTED THAT THE AS-IFS1, AIRSEAL IFS, 110V DEVICE WAS BEING USED DURING A MILES' PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED THAT "DURING LAPAROSCOPIC MILES' OPERATION, CO2 GAS EMBOLISM OCCURRED. SATURATION RAPIDLY DECREASED. CARDIAC MASSAGE WAS DONE. THE PATIENT RECOVERED.¿ FURTHER ASSESSMENT HAS BEEN SENT; HOWEVER, TO DATE NO RESPONSE HAS BEEN RECEIVED. IF MORE INFORMATION IS RECEIVED THIS COMPLAINT WILL BE UPDATED. THIS REPORT IS BEING RAISED ON THE BASIS INJURY OF DUE TO GAS EMBOLISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1810294 AIRSEAL IFS, 110V INSUFFLATOR, LAPAROSCOPIC HIF W.O.M WORLD OF MEDICINE GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R