BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRSEAL IFS, 110V

    MDR report key: 11777172 · Received May 5, 2021

    Report

    Report Number
    1320894-2021-00210
    Event Type
    Injury
    Date Received
    May 5, 2021
    Date of Event
    April 14, 2021
    Report Date
    May 5, 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 · 1

    ADDITIONAL FDA PRODUCT CODE: GCJ. MANUFACTURER NARRATIVE: THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AND NO PHOTOGRAPHIC EVIDENCE WAS PROVIDED THEREFORE ROOT CAUSE CANNOT BE IDENTIFIED. A DHR REVIEW CONDUCTED BY THE VENDOR INDICATES (B)(4) DEVICES WERE MANUFACTURED UNDER THE SAME WORK ORDER AND ACCEPTED INTO FINAL STOCK IN AUG 2019 WITH NO REPORTED DISCREPANCIES. THE SERVICE HISTORY WAS REVIEWED, AND NO DATA WAS FOUND. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THAT INSUFFLATION OF CO2 SHOULD BE DONE CAREFULLY AND WHILE MONITORING THE PATIENT'S RESPONSE. THE USER, PARTICULARLY THE ANESTHETIST, SHOULD BE INFORMED ABOUT POSSIBLE CARDIOVASCULAR AND RESPIRATORY PROBLEMS OF THE PATIENT AND MONITOR THESE INTRA-OPERATIVELY. THE IFU ALSO WARNS THE USER THAT INSUFFLATING CO2 MAY RESULT IN METABOLIC ACIDOSIS. THIS CAN LEAD TO CARDIAC IRREGULARITIES EXPRESSED WITH THE FOLLOWING SYMPTOMS: REDUCED ASPIRATION WITH RESTRICTED DIAPHRAGM FUNCTIONS, HYPERCAPNIA AND REDUCED CARDIAC OUTPUT. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE, AS-IFS1, WAS BEING USED DURING LAPAROSCOPIC PARTIAL LIVER RESECTION ON (B)(6) 2021 WHEN IT WAS REPORTED "AFTER THE SURGERY, THE PATIENT HAD STROKE." THE PROCEDURE HAD BEEN COMPLETED WHEN THE STROKE OCCURRED. THERE WAS NO REPORT OF DEVICE MALFUNCTION; ONLY THAT THE DEVICE HAD BEEN USED DURING THE PROCEDURE. THERE WAS NO REPORT OF ANY TYPE OF DELAY DURING THE PROCEDURE AND NO REPORT OF AN ALTERNATE DEVICE BEING USED DURING THE PROCEDURE. FURTHER ASSESSMENT QUESTIONS WERE ASKED OF THE REPORTER; HOWEVER, TO DATE THERE HAS BEEN NO RESPONSE. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO PATIENT HAVING STROKE AFTER PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672920 AIRSEAL IFS, 110V INSUFFLATOR, LAPAROSCOPIC HIF W.O.M. WORLD OF MEDICINE GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other