BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRSEAL IFS, 230V

    MDR report key: 12019510 · Received June 17, 2021

    Report

    Report Number
    1320894-2021-00303
    Event Type
    Injury
    Date Received
    June 17, 2021
    Date of Event
    April 26, 2021
    Report Date
    August 27, 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 DEVICE WILL NOT BE RETURNED FOR EVALUATION AND NO PHOTOGRAPHIC EVIDENCE WAS PROVIDED; ADDITIONALLY, FOLLOW UP INFORMATION PROVIDED BY THE REPORTER INDICATED THAT THE EVENT WAS CAUSED BY USER ERROR AND THE DEVICE HAD NOT MALFUNCTIONED. 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 THE SERVICE DATA FOUND IS NOT RELATED TO THIS COMPLAINT AS THE DEVICE WAS NOT RETURNED AND SERVICED FOR THIS ISSUE. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF ONE COMPLAINT, REGARDING ONE DEVICE, 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). 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. 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 ¿AT THE END OF THE SURGERY THE PATIENT HAS A PERIORBITAL EDEMA.¿. 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 PERIORBITAL EDEMA.

    Additional Manufacturer Narrative · 1

    ADDITIONAL FDA PRODUCT CODE: GCJ HEALTH EFFECT CLINICAL, NO CODE FOR PERIORBITAL EDEMA 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 BARIATRIC SURGERY ON (B)(6) 2021 WHEN IT WAS REPORTED ¿AT THE END OF THE SURGERY THE PATIENT HAS A PERIORBITAL EDEMA.¿. 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 PERIORBITAL EDEMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914670 AIRSEAL IFS, 230V INSUFFLATOR, LAPAROSCOPIC HIF W.O.M. WORLD OF MEDICINE GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other