BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRSEAL IFS, 230V

    MDR report key: 11982674 · Received June 11, 2021

    Report

    Report Number
    1320894-2021-00296
    Event Type
    Injury
    Date Received
    June 11, 2021
    Date of Event
    February 10, 2021
    Report Date
    July 26, 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
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DIAGNOSTICS EVALUATION FOUND THE PM WAS NOT OVERDUE, AND THE UNIT WAS NOT MISUSED. ADDITIONAL PROBLEMS WERE FOUND. THE RESPONSE TIME AND CALIBRATION FAILED. THE UNIT WAS SERVICED, AND THE OXYGEN SENSOR WAS REPLACED. A DEVICE HISTORY RECORD REVIEW WAS REQUESTED FROM THE MANUFACTURER, AND A RESPONSE WAS NOT RECEIVED. THE SERVICE HISTORY WAS REVIEWED. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF (B)(4) COMPLAINTS, REGARDING (B)(4) DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME (B)(4) DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THAT HIGHER INSUFFLATION PRESSURES (>15MM HG) OF CARBON DIOXIDE INSUFFLATION CAN INCREASE THE RISK OF HYPERCARBIA, SUBCUTANEOUS EMPHYSEMA, PNEUMOMEDIASTINUM, PNEUMOTHORAX, PNEUMOSCROTUM AND URINARY RETENTION. FAILURE TO PROPERLY FOLLOW THE INSTRUCTIONS FOR USE CAN LEAD TO SERIOUS SURGICAL CONSEQUENCES. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL FDA PRODUCT CODE: GCJ. (B)(4). MANUFACTURE 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 LAPARSCOPIC HYSTERECTOMY ON (B)(6) 2021 WHEN IT WAS REPORTED "THE ANESTHETIST DETECTS THE APPEARANCE OF SUBCUTANEOUS DURING A LAPARSCOPY". 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
    877724 AIRSEAL IFS, 230V INSUFFLATOR, LAPAROSCOPIC HIF W.O.M. WORLD OF MEDICINE GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other