BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRSEAL IFS, 110V

    MDR report key: 14053302 · Received April 8, 2022

    Report

    Report Number
    1320894-2022-00073
    Event Type
    Injury
    Date Received
    April 8, 2022
    Date of Event
    March 10, 2022
    Report Date
    April 8, 2022
    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. THE REPORTED EVENT OF ¿WHEN THE COVER CLOTH WAS REMOVED, THE PATIENT DEVELOPED SCROTAL EMPHYSEMA¿ IS INCONCLUSIVE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AND NO PHOTOGRAPHIC EVIDENCE WAS PROVIDED; THEREFORE, ROOT CAUSE CANNOT BE IDENTIFIED. THE SERVICE HISTORY WAS REVIEWED, AND NO DATA WAS FOUND. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 8 REPORTS, REGARDING 8 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE.(B)(4).THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    CONMED (B)(6) REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, AS-IFS1, AIRSEAL IFS, 110V WAS BEING USED ON (B)(6) 2022 DURING A ROBOTICALLY-ASSISTED LAPAROSCOPIC RECTAL CANCER PROCEDURE WHEN IT WAS REPORTED ¿AFTER THE OPERATION, WHEN THE COVER CLOTH WAS REMOVED, IT WAS CONFIRMED THAT THE PATIENT DEVELOPED SCROTAL EMPHYSEMA. THE PATIENT WAS IN REMISSION A FEW DAYS LATER. THE PROCEDURE WAS COMPLETED AND THERE WAS NO DELAY. FURTHER ASSESSMENT FOUND ¿THE GAS SETTINGS WERE SMOKE EXHAUST : LOW. INITIAL INSUFFLATION 20L. INSUFFLATION AT 5L AT THE BEGINNING OF CAMERA PORT PLACEMENT. AFTER IT IS CONFIRMED THAT IT IS IN, INCREASE TO 20L.¿ MEDICALLY PURE CO2 WAS USED. THE PATIENT DOESN¿T HAVE CO-MORBIDITIES; HOWEVER, BMI IS IN THE ¿LOW 20S, BELOW 30¿. NO MEDICAL TREATMENT WAS NEEDED, THE PATIENT HAD "SPONTANEOUS RECOVERY" AND IS CURRENTLY IN REMISSION AFTER A FEW DAYS. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO SCROTAL EMPHYSEMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188280 AIRSEAL IFS, 110V INSUFFLATOR, LAPAROSCOPIC HIF W.O.M. WORLD OF MEDICINE GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other