BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRSEAL 12/100MM LPI PORT

    MDR report key: 16543984 · Received March 15, 2023

    Report

    Report Number
    3007305485-2023-00053
    Event Type
    Malfunction
    Date Received
    March 15, 2023
    Date of Event
    February 24, 2023
    Report Date
    May 1, 2023
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT COMPANY
    Product Code
    GCJ
    UDI-DI
    10845854045640
    PMA / PMN Number
    K190303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 0

    RECEIVED ONE IAS12-100LPI IN ORIGINAL OPENED PACKAGE. LOT NUMBER WAS VERIFIED. PERFORMED A VISUAL INSPECTION, THE COMPLAINT WAS CONFIRMED. THE TIP OF THE TROCAR WAS FRACTALATED. 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. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 40 REPORTS, REGARDING 43 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME 1,041,120 DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE.(B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: USE EXTREME CAUTION DURING AIRSEAL ACCESS PORT INSERTION. IMPROPER USE OF THIS PRODUCT CAN RESULT IN LIFE-THREATENING INJURY TO INTERNAL ORGANS AND VESSELS. ENSURE THAT ADEQUATE PNEUMOPERITONEUM OR PNEUMORECTUM IS ESTABLISHED; ENSURE THAT THE PATIENT IS PROPERLY POSITIONED SO THAT ORGANS ARE AWAY FROM THE PENETRATION SITE; DIRECT THE AIRSEAL ACCESS PORT¿S TIP AWAY FROM SIGNIFICANT VESSELS AND ORGANS; DO NOT USE EXCESSIVE DOWNWARD FORCE AND ONCE A SAFE AND PROPER ENTRY HAS BEEN ACHIEVED, ENSURE THAT THE BLACK LINE AT THE DISTAL TIP OF THE AIRSEAL ACCESS PORT IS VISIBLE WITHIN THE CAVITY AT ALL TIMES THE AIRSEAL ACCESS PORT IS BEING USED FOR INSUFFLATION. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    CONMED JAPAN REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, IAS12-100LPI, AIRSEAL 12/100MM LPI PORT WAS BEING USED ON (B)(6) 2023 DURING A THORACIC ESOPHAGECTOMY AND ¿IN A CASE OF THORACOSCOPIC ESOPHAGECTOMY, THE FACILITY FOUND THE TROCAR TIP TO BE FRACTURED (MISSING TIP) DURING SURGERY. SINCE THE DAMAGED TIP WAS REMOVED IMMEDIATELY, IT WAS CONFIRMED THAT THERE WAS NO RESIDUE ON THE PATIENT. THE SURGERY WAS COMPLETED WITHOUT ANY DELAYS OR HEALTH PROBLEMS.¿. THE PROCEDURE WAS COMPLETED WITHOUT AN ALTERNATE DEVICE. THERE WAS NO INJURY OR IMPACT TO THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Description of Event or Problem · 0

    CONMED JAPAN REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, IAS12-100LPI, AIRSEAL 12/100MM LPI PORT WAS BEING USED ON 24FEB23 DURING A THORACIC ESOPHAGECTOMY AND ¿IN A CASE OF THORACOSCOPIC ESOPHAGECTOMY, THE FACILITY FOUND THE TROCAR TIP TO BE FRACTURED (MISSING TIP) DURING SURGERY. SINCE THE DAMAGED TIP WAS REMOVED IMMEDIATELY, IT WAS CONFIRMED THAT THERE WAS NO RESIDUE ON THE PATIENT. THE SURGERY WAS COMPLETED WITHOUT ANY DELAYS OR HEALTH PROBLEMS.¿. THE PROCEDURE WAS COMPLETED WITHOUT AN ALTERNATE DEVICE. THERE WAS NO INJURY OR IMPACT TO THE PATIENT. 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
    914006 AIRSEAL 12/100MM LPI PORT LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ CONSOLIDATED MEDICAL EQUIPMENT COMPANY IAS12-100LPI 202205065 10845854045640

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown