BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRSEAL IFS, 230V

    MDR report key: 12028339 · Received June 18, 2021

    Report

    Report Number
    1320894-2021-00304
    Event Type
    Injury
    Date Received
    June 18, 2021
    Date of Event
    April 7, 2021
    Report Date
    August 27, 2021
    Manufacturer
    CONMED UTICA
    Product Code
    HIF
    PMA / PMN Number
    K190303
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR CHECK ONLY AS THE DISTRIBUTOR REPORTED THAT THE EVENT WAS CAUSED BY USER ERROR. ADDITIONALLY, EVALUATION OF THE DEVICE FOUND SENSOR ERROR AND CALIBRATION FAILURE. PARTS WERE REPLACED AND THE DEVICE REPAIRED. A DEVICE HISTORY RECORD REVIEW HAS BEEN REQUESTED OF THE VENDOR HOWEVER, NO RESPONSE HAS BEEN RECEIVED TO DATE. THE SERVICE HISTORY WAS REVIEWED, AND NO PREVIOUS SERVICE DATA WAS FOUND. (B)(4). SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED FOR THIS REPORTED FAILURE, THE RATE OF FAILURE WOULD BE 0.004. PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THAT FAILURE TO FOLLOW THE INSTRUCTIONS FOR USE CAN LEAD TO SERIOUS SURGICAL CONSEQUENCES. ONLY QUALIFIED PHYSICIANS WITH KNOWLEDGE, EXPERIENCE AND TRAINING IN LAPAROSCOPIC TECHNIQUES SHOULD USE THE COMPONENTS OF THE AIRSEAL ACCESS SYSTEM. THE IFU ALSO ADVISES THE USER THAT 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 DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE AS-IFS2 WAS BEING USED DURING A BARIATRIC SURGERY ON (B)(6) 2021 WHEN IT WAS REPORTED ¿A THORACIC SUBCUTANEOUS EMPHYSEMA IS DETECTED AT THE END OF THE SURGERY.¿. FURTHER ASSESSMENT QUESTIONS WERE SENT TO THE USER FACILITY; HOWEVER, THEY DECLINED TO ANSWER ANYTHING FURTHER. FOLLOW UP WITH THE MARKETING MANAGER FOUND THAT THE DISTRIBUTOR HAS REPORTED THAT THIS INCIDENT WAS CAUSE BY USER ERROR AND THE CONMED DEVICE HAS NOT MALFUNCTIONED. THE FACILITY IS SCHEDULED FOR RETRAINING OF THE NEW PERSONNEL. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO REPORT OF SUBCUTANEOUS EMPHYSEMA.

    Additional Manufacturer Narrative · 1

    ADDITIONAL FDA PRODUCT CODE: GCJ HEALTH EFFECT CLINICAL, NO CODE FOR SUBCUTANEOUS EMPHYSEMA MANUFACTURER NARRATIVE: THE REPORTED DEVICE IS BEING RETURNED TO CONMED FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE AS-IFS2 WAS BEING USED DURING A BARIATRIC SURGERY ON (B)(6) 2021 WHEN IT WAS REPORTED ¿A THORACIC SUBCUTANEOUS EMPHYSEMA IS DETECTED AT THE END OF THE SURGERY.¿ FURTHER ASSESSMENT QUESTIONS WERE SENT TO THE USER FACILITY; HOWEVER, THEY DECLINED TO ANSWER ANYTHING FURTHER. FOLLOW UP WITH THE MARKETING MANAGER FOUND THAT THE DISTRIBUTOR HAS REPORTED THAT THIS INCIDENT WAS CAUSE BY USER ERROR AND THE CONMED DEVICE HAS NOT MALFUNCTIONED. THE FACILITY IS SCHEDULED FOR RETRAINING OF THE NEW PERSONNEL. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO REPORT OF SUBCUTANEOUS EMPHYSEMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920441 AIRSEAL IFS, 230V INSUFFLATOR, LAPAROSCOPIC HIF CONMED UTICA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other