BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRSEAL IFS, 110V

    MDR report key: 19566349 · Received June 19, 2024

    Report

    Report Number
    1320894-2024-00162
    Event Type
    Malfunction
    Date Received
    June 19, 2024
    Report Date
    July 11, 2024
    Manufacturer
    W.O.M. WORLD OF MEDICINE GMBH
    Product Code
    HIF
    UDI-DI
    10851885004587
    PMA / PMN Number
    K190303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT OF ¿THE SYSTEM ABRUPTLY LOST PNEUMO SEVERAL TIMES DURING THE CASE¿ WAS INCONCLUSIVE; HOWEVER, ADDITIONAL PROBLEM FOUND. THE POWER CONNECTIONS INCLUDING CABLE SET, CIRCUIT BREAKER, POWER MODULE AND POWER SUPPLY WERE CHECKED. THE LPU (LOW PRESSURE UNIT) FAILED DUE TO LOW PRESSURE CALIBRATION. ELECTRICAL SAFETY WAS TESTED, AND THE UNIT WAS PLACED IN 12-HOUR BURN-IN. THE UNIT WAS REPAIRED UNIT, AND CALIBRATED. 12-HOUR TEST PASSED. THE UNIT WAS TESTED PER IP-800-031 AND FUNCTIONS PER THE SPECIFICATION. THE SERVICE HISTORY WAS REVIEWED AND NO RELATIONSHIP TO THIS COMPLAINT WAS FOUND. A DEVICE HISTORY RECORD (DHR) REVIEW WAS REQUESTED FROM THE MANUFACTURER, AND NO INDICATION OF ABNORMALITIES WAS COMMUNICATED. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 10 REPORTS, REGARDING 10 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). WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE HAS BEEN RETURNED TO CONMED; HOWEVER, THE INVESTIGATION OF THE DEVICE HAS NOT BEEN COMPLETED. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE AND COMPLAINT INVESTIGATION. WE WILL CONTINUE TO MONITOR FOR TRENDS 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 BEING USED DURING A ROBOTIC HYSTERECTOMY AND THE ¿AIRSEAL SHUTTING OFF RANDOMLY DURING CASES. WAS PM IN (B)(6) 2024. PER FURTHER ASSESSMENT IT WAS FOUND "THE SYSTEM ABRUPTLY LOST PNEUMO SEVERAL TIMES DURING THE CASE. THIS WAS THE FIRST TIME THIS HAPPENED AND THEY WERE ABLE TO COMPLETE THE CASE WITH THE SAME AIRSEAL.¿. THERE WAS NO IMPACT OR INJURY TO THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Description of Event or Problem · 0

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE AS-IFS1, AIRSEAL IFS, 110V WAS BEING USED DURING A ROBOTIC HYSTERECTOMY AND THE ¿AIRSEAL SHUTTING OFF RANDOMLY DURING CASES. WAS PM IN FEB 2024. PER FURTHER ASSESSMENT IT WAS FOUND "THE SYSTEM ABRUPTLY LOST PNEUMO SEVERAL TIMES DURING THE CASE. THIS WAS THE FIRST TIME THIS HAPPENED AND THEY WERE ABLE TO COMPLETE THE CASE WITH THE SAME AIRSEAL.¿. THERE WAS NO IMPACT OR INJURY TO THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640958 AIRSEAL IFS, 110V INSUFFLATOR, LAPAROSCOPIC HIF W.O.M. WORLD OF MEDICINE GMBH 10851885004587

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown