BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPAROSCOPIC SMOKE EVAC TUBING SET

    MDR report key: 9706035 · Received February 13, 2020

    Report

    Report Number
    1320894-2020-00068
    Event Type
    Malfunction
    Date Received
    February 13, 2020
    Report Date
    March 31, 2020
    Manufacturer
    BUFFALO FILTER
    Product Code
    FYD
    PMA / PMN Number
    K924732
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10, H3: ALTHOUGH THE DEVICE IN QUESTION IS MANUFACTURED BY BUFFALO FILTER, A PRELIMINARY EVALUATION WAS PERFORMED BY CONMED. THE DEVICE WILL BE FORWARDED ON TO BUFFALO FILTER, THE MANUFACTURER AS WELL. H10: THE REPORTED EVENT OF INSUFFICIENT HEAT SEAL IS CONFIRMED. CONMED RECEIVED ONE 60-6810-001 IN UNOPENED ORIGINAL PACKAGING. THE LOT NUMBER WAS VERIFIED. A VISUAL INSPECTION WAS PERFORMED AND FOUND THE SEAL WAS NOT LINED UP PROPERLY. PERFORMED A FUNCTIONAL INSPECTION WITH DYE LEAK TESTING PER PROCEDURE WHICH INDICATED THAT THE PACKAGING DID HAVE AN INSUFFICIENT HEAT SEAL. ALTHOUGH A LOT NUMBER WAS PROVIDED, CONMED COULD NOT CONDUCT A TWO-YEAR LOT HISTORY REVIEW OR REVIEW THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD (DHR) AS THE DEVICE IS MANUFACTURED BY BUFFALO FILTER FOR CONMED. A RISK ANALYSIS CANNOT BE CONDUCTED FOR THIS DEVICE SINCE CONMED DOES NOT OWN THE RISK DOCUMENTS FOR THIS DEVICE. A TWO-YEAR LOT HISTORY REVIEW SHOWS THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE. A TWO-YEAR REVIEW OF COMPLAINT HISTORY FOR THIS DEVICE FAMILY AND FAILURE MODE, REVEALED THERE HAS BEEN A TOTAL OF 1 COMPLAINTS, REGARDING 1 DEVICE, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME 77,955 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 (B)(4). 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

    AT TIME OF FILING, ALTHOUGH EXPECTED, THE REPORTED DEVICE HAS NOT BEEN 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

    DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, CATALOG # 60-6810-001, LAPAROSCOPIC SMOKE EVAC TUBING SET , LOT 140843, FOR A POSSIBLE INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. DUE TO THE POTENTIAL SEVERITY OF A BREACH IN STERILITY, THIS REPORT IS BEING RAISED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172984 LAPAROSCOPIC SMOKE EVAC TUBING SET APPARATUS, EXHAUST, SURGICAL FYD BUFFALO FILTER 140843

    Patients

    Seq Age Sex Outcome Treatment
    1