BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRSEAL IFS, 110V

    MDR report key: 11649554 · Received April 12, 2021

    Report

    Report Number
    1320894-2021-00170
    Event Type
    Injury
    Date Received
    April 12, 2021
    Date of Event
    March 26, 2021
    Report Date
    April 12, 2021
    Manufacturer
    W.O.M WORLD OF MEDICINE GMBH
    Product Code
    HIF
    PMA / PMN Number
    K143404
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE; GCJ. INVESTIGATION OF THE CUSTOMER'S REPORTED ISSUE AND COMPLAINT WAS INCONCLUSIVE. THE DEVICE IS NOT BEING RETURNED AND NO PHOTOGRAPHIC EVIDENCE WAS PROVIDED. THEREFORE, THE REPORTED FAILURE CANNOT BE VERIFIED, AND ROOT CAUSE CAN NOT BE IDENTIFIED. AS A SERIAL NUMBER WAS NOT PROVIDED, CONMED COULD NOT CONDUCT A REVIEW OF THE SERVICE HISTORY OR REVIEW THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD (DHR) REPORTS. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 7 COMPLAINTS, REGARDING 7 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME 1864 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 0.004, HOWEVER, BECAUSE THIS IS A REUSABLE DEVICE, THE POTENTIAL NUMBER OF USES IS NOT CONSIDERED IN THIS OCCURRENCE RATE. THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE USER WITH INFORMATION REGARDING PROPER CARE AND USE OF THIS DEVICE. THE IFU ALSO ADVISES THE USER THAT HIGHER INSUFFLATION PRESSURES (> 15 MM HG) OF CARBON DIOXIDE INSUFFLATION CAN INCREASE THE RISK OF HYPERCARBIA, SUBCUTANEOUS EMPHYSEMA, PNEUMOMEDIASTINUM, PNEUMOTHORAX, PNEUMOSCROTUM AND URINARY RETENTION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    CONMED PRODUCT TECH SUPPORT RECEIVED A CALL FROM (B)(6) MEDICAL CENTER REGARDING ISSUES WITH THE AS-IFS1, AIRSEAL IFS UNIT, SERIAL NUMBER UNKNOWN THAT OCCURRED ON (B)(6)2021. THE PRODUCT TECH SUPPORT CONTACTED THE CONMED SALES REPRESENTATIVE WHO VISITED THE MEDICAL CENTER TO FOLLOW UP. IT WAS REPORTED THAT PATIENT HAD ISSUE WITH SUB Q. THE FACILITY REPORTS THE ISSUE HAD NOTHING TO DO WITH THE CONMED DEVICE/MACHINE. THE REPORTER, OR CHARGE NURSE (B)(6), WAS ADAMANT THAT THE CONMED AIRSEAL WAS NOT THE CONCERN, IT HAD NOTHING TO DO WITH THE AIRSEAL AND THE DOCTOR DID NOT WANT TO DISCUSS IT FURTHER. THE PROCEDURE WAS A DIAGNOSTIC LAPAROSCOPIC GYN PROCEDURE WHICH WAS SUCCESSFULLY COMPLETED. IT IS UNKNOWN IF THE SUB Q OCCURRED DURING OR AFTER PROCEDURE. FACILITY WANTS NO FOLLOW UP AND NO FURTHER DISCUSSION. PATIENT WAS (B)(6)YRS OLD, FEMALE, (B)(6)KG IN WEIGHT, HER CURRENT CONDITION IS REPORTED TO BE "FINE" WITH NO IMPACT/INJURY. ALTHOUGH REQUESTED, NO OTHER INFORMATION OR INCIDENT DETAILS WERE MADE AVAILABLE BY THE FACILITY AND THEY WANT NO FURTHER CONTACT. ALTHOUGH THERE IS NO ALLEGATION OF DEFECT OR FAULT WITH THE AIRSEAL UNIT, THIS MDR REPORTING IS BEING RAISED ON THE BASIS OF INJURY FOR THE MENTION OF SUB Q.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547838 AIRSEAL IFS, 110V INSUFFLATOR, LAPAROSCOPIC HIF W.O.M WORLD OF MEDICINE GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other