BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRSEAL 12/100MM LPI PORT

    MDR report key: 14913819 · Received July 5, 2022

    Report

    Report Number
    3007305485-2022-00087
    Event Type
    Malfunction
    Date Received
    July 5, 2022
    Date of Event
    May 18, 2022
    Report Date
    July 22, 2022
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT COMPANY
    Product Code
    GCJ
    UDI-DI
    10845854045640
    PMA / PMN Number
    K190303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION AND REVIEW. HOWEVER, THE COMPLAINT INVESTIGATION IS NOT COMPLETE AT THIS TIME . A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE COMPLAINT INVESTIGATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 0

    THE DEVICE IAS12-100LPI IS NOT EXPECTED TO BE RETURNED FOR EVALUATION AND REVIEW. THIS COMPLAINT IS UNABLE TO BE VERIFIED AND A ROOT CAUSE CANNOT BE DETERMINED. 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. THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE WITHIN THE PAST TWO YEARS. (B)(4). PER THE IFU W55-000-983 AB, FAILURE TO PROPERLY 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 SYSTEM. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE IAS12-100LPI, AIRSEAL 12/100MM LPI PORT WAS BEING USED ON (B)(6) 2022 DURING A ROBOTIC PROCEDURE WHEN IT WAS REPORTED THAT SHAFT OF THE TROCAR STAYED IN THE PATIENT. THE CASE WAS FINISHED WITHOUT PATIENT HARM, BUT INCIDENT REPORT WAS FILED AS THIS PUTS THE PATIENT AT RISK FOR INJURY AS WELL AS OTHER POTENTIAL ISSUES. FURTHER ASSESSMENT ANSWERS WERE REQUESTED OF THE REPORTER AND A GOOD FAITH EFFORT WAS COMPLETED; HOWEVER, THE REPORTER HAS NOT RESPONDED TO OUR ATTEMPTS FOR INFORMATION. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Description of Event or Problem · 0

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE IAS12-100LPI, AIRSEAL 12/100MM LPI PORT WAS BEING USED ON (B)(6) 2022 DURING A ROBOTIC PROCEDURE WHEN IT WAS REPORTED THAT ¿SHAFT OF THE TROCAR STAYED IN THE PATIENT. THE CASE WAS FINISHED WITHOUT PATIENT HARM, BUT INCIDENT REPORT WAS FILED AS THIS PUTS THE PATIENT AT RISK FOR INJURY AS WELL AS OTHER POTENTIAL ISSUES.¿ FURTHER ASSESSMENT ANSWERS WERE REQUESTED OF THE REPORTER AND A GOOD FAITH EFFORT WAS COMPLETED; HOWEVER, THE REPORTER HAS NOT RESPONDED TO OUR ATTEMPTS FOR INFORMATION. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1162016 AIRSEAL 12/100MM LPI PORT LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ CONSOLIDATED MEDICAL EQUIPMENT COMPANY IAS12-100LPI 202103204 10845854045640

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown