BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRSEAL 8/12000 PORT

    MDR report key: 9570078 · Received January 9, 2020

    Report

    Report Number
    1320894-2019-00443
    Event Type
    Malfunction
    Date Received
    January 9, 2020
    Date of Event
    December 11, 2019
    Report Date
    February 6, 2020
    Manufacturer
    SEQUEL SPECIAL PRODUCTS
    Product Code
    GCJ
    PMA / PMN Number
    K143404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED ONE IAS8-120LP IN OPENED ORIGINAL PACKAGING. LOT NUMBER WAS VERIFIED. PERFORMED A VISUAL INSPECTION, MULTIPLE PIECE OF THE DEVICE WERE DETACHED. THE RUBBER SEAL HAD BEEN TORN APART. THE PLUG FOR THE TRI-LUMEN CONNECTOR WAS DETACHED FROM THE DEVICE. THE DEVICE IS MANUFACTURED BY SEQUEL SPECIAL PRODUCT; A DHR REVIEW REQUEST WAS MADE HOWEVER, NO REVIEW HAS BEEN RECEIVED TO DATE.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 12 COMPLAINTS REGARDING 12 DEVICES FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THE SAME TIME FRAME (B)(4) HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING; FAILURE TO PROPERLY FOLLOW THE INSTMM, RUCTIONS FOR USE CAN LEAD TO SERIOUS SURGICAL CONSEQUENCES. IF USING THE OPTIONAL SOUND CAP (8MM,12MM) INSPECT THE SOUND CAP BLUE FOAM AND BLUE SEAL PRIOR TO USE. USE CAUTION WHEN INSERTING A SHARP OR LARGE DEVICE THROUGH THE CANNULA. INSPECT THE SOUND CAP AFTER USE FOR PHYSICAL DAMAGE OF ANY KIND. CONMED ENCOURAGES THE INSPECTION AND/OR TEST OF ALL MEDICAL EQUIPMENT PRIOR TO USE TO ENSURE ALL DEVICES ARE FUNCTIONING AS EXPECTED. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED AND THE COMPLAINT INVESTIGATION IS ONGOING. 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 IAS8-120LP, AIRSEAL 8/120MM PORT'S DIAPHRAGM CAME APART DURING A ROBOTIC OVARIAN CYSTECTOMY ON (B)(6) 2019. ALL OF PIECES WERE REMOVED FROM PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME TROCAR. THERE WAS NO REPORTED PATIENT INJURY OR IMPACT. THERE WAS NO REPORTED DELAY OF SURGERY. THIS REPORT IS BEING RAISED BASED ON DEVICE MALFUNCTION AND THE POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32343 AIRSEAL 8/12000 PORT PORT/TROCAR GCJ SEQUEL SPECIAL PRODUCTS 126219

    Patients

    Seq Age Sex Outcome Treatment
    1