BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRSEAL IFS, 110V

    MDR report key: 10704450 · Received October 20, 2020

    Report

    Report Number
    3006217371-2020-00457
    Event Type
    Injury
    Date Received
    October 20, 2020
    Report Date
    December 9, 2020
    Manufacturer
    W.O.M. WORLD OF MEDICINE GMBH
    Product Code
    HIF
    PMA / PMN Number
    K143404
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION OF THE RETURNED DEVICE FOUND NO FAULT. THE COMPRESSOR AGE IS 1 YEAR, 9 MONTHS. ((B)(6) 2019). PERFORMED THE ANNUAL INSPECTION WITH NO PROBLEMS. CALIBRATED UNIT, PERFORMED SAFETY TEST, AND PLACED THE UNIT INTO 12 BURN-IN. THE UNIT COMPLETED AND PASSED THE 12-HOUR BURN-IN TEST. THE UNIT WAS TESTED PER IP-800-031. THE UNIT FUNCTIONS AS PER THE SPECIFICATION. A REVIEW OF THE DHR BY THE CONTRACT MANUFACTURER INDICATED THAT 6 DEVICES WERE MANUFACTURED WITH THE WORK ORDER AND ACCEPTED INTO FINAL STOCK IN (B)(6) 2015 WITH NO REPORTED DISCREPANCIES. THE SERVICE HISTORY WAS REVIEWED AND NO RELATIONSHIP TO THIS COMPLAINT WAS FOUND. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 9 COMPLAINTS, REGARDING 9 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME 1,959 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 0.005. PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: PRECAUTIONS: HIGHER INSUFFLATION PRESSURES (> 15 MM HG) OF CARBON DIOXIDE INSUFFLATION CAN INCREASE THE RISK OF HYPERCARBIA, SUCUTANEOUS EMPHYSEMA, PNEUMOMEDIASTINUM, PNEUMOTHORAX, PNEUMOSCROTUM, AND URINARY RETENTION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 1

    SECONDARY FDA PRODUCT CODE IS GCJ. (B)(4). 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 CUSTOMER REPORTED THAT THE DEVICE, AS-IFS1, CAUSED SUBCUTANEOUS EMPHYSEMA TO A PATIENT ON AN UNKNOWN DATE AND DURING AN UNKNOWN PROCEDURE. FURTHER ASSESSMENT QUESTIONING WAS REQUESTED; HOWEVER, THE SURGEON WILL NOT RESPOND. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE SUBCUTANEOUS EMPHYSEMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1170514 AIRSEAL IFS, 110V INSUFFLATOR, LAPAROSCOPIC HIF W.O.M. WORLD OF MEDICINE GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other