BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRSEAL 12/100MM LPI PORT

    MDR report key: 11819014 · Received May 13, 2021

    Report

    Report Number
    3007305485-2021-00240
    Event Type
    Injury
    Date Received
    May 13, 2021
    Date of Event
    April 15, 2021
    Report Date
    June 7, 2021
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT
    Product Code
    HIF
    PMA / PMN Number
    K190303
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT IS CONFIRMED. CUSTOMER EVENT "TIP OF TROCAR PARTIALLY DAMAGED" WAS CONFIRMED BASED ON PHOTOGRAPHIC EVIDENCE AND DEVICE EVALUATION. RECEIVED ONE IAS12-100LPI OPENED IN UNORIGINAL PACKAGING. THE LOT NUMBER OF THE DEVICE WAS NOT VERIFIED. A VISUAL INSPECTION FOUND THE SERRATED THREADED CANNULA CRACKED AND BROKEN ON THE DISTAL END. THREE PIECES THAT BROKE OFF THE CANNULA WERE RETURNED. A TWO-YEAR LOT HISTORY REVIEW CANNOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. A DEVICE HISTORY REVIEW CANNOT NOT BE CONDUCTED AS NO LOT NUMBER WAS PROVIDED. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 11 COMPLAINTS, REGARDING 15 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME 845,958 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 0.00002. PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: FAILURE TO PROPERLY FOLLOW THE INSTRUCTIONS FOR USE CAN LEAD TO SERIOUS SURGICAL CONSEQUENCES. ONLY QUALIFIED PHYSICIANS WITH KNOWLEDGE, EXPERIENCE AND TRAINING IN LAPAROSCOPIC TECHNIQUE SHOULD USE THE COMPONENTS OF THE AIRSEAL ACCESS SYSTEM. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: GCJ. MANUFACTURER 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 IAS12-100LPI WAS BEING USED ON (B)(6) 2021 DURING A THORACOSCOPIC SURGERY FOR VERTICAL SEPTAL ULCERS WHEN IT WAS REPORTED THE "IAS12-100LPI WAS USED AS A CAMERA PORT. WHEN THE TROCAR WAS REMOVED NEAR THE CLOSING OF THE SURGERY, IT WAS NOTICED THAT THE TIP OF THE TROCAR WAS PARTIALLY DAMAGED. IT IS UNCLEAR AT WHAT POINT IN THE OPERATION THIS OCCURRED. AFTER RETRIEVING SOME OF THE LARGER FRAGMENTS, THE INSIDE OF THE BODY WAS WASHED AND ASPIRATED WITH 3,000 ML OF WATER TO CONFIRM WHETHER ANY FRAGMENTS STILL REMAINED IN THE BODY. AT THAT TIME, THEY USED X-RAYS TO CHECK UNDER MAGNIFICATION, HOWEVER NO FRAGMENTS WERE FOUND." AFTER FURTHER ASSESSMENT, IT WAS FOUND THAT THE SURGEON WAS UNSURE IF ALL THE FRAGMENTS WERE RETRIEVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR ANY KNOWN HOSPITALIZATION FOR THE PATIENT. THERE WAS ABOUT AN HOUR DELAY. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO NOT KNOWING IF ALL FRAGMENTS WERE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712810 AIRSEAL 12/100MM LPI PORT INSUFFLATOR, LAPAROSCOPIC HIF CONSOLIDATED MEDICAL EQUIPMENT UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other