BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE SET, SMOKE EVAC, LAPAROSCOPIC

    MDR report key: 10627292 · Received October 5, 2020

    Report

    Report Number
    3007305485-2020-00439
    Event Type
    Malfunction
    Date Received
    October 5, 2020
    Report Date
    December 30, 2020
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT
    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

    THE CUSTOMER'S REPORTED COMPLAINT OF AN INSUFFICIENT HEAT SEAL LEADING TO A BREACH IN STERILITY IS CONFIRMED. CONMED RECEIVED ONE 60-6810-001 IN UNOPENED ORIGINAL PACKAGING, THE REPORTED CATALOG AND LOT NUMBERS WERE VERIFIED. A VISUAL INSPECTION WAS PERFORMED AND FOUND THERE IS A LARGE OPEN HOLE IN THE SEAL, WHICH INDICATES THAT THE PACKAGING DID HAVE A BREACH IN STERILITY. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED AND FOUND NO ABNORMALITIES THAT WOULD CONTRIBUTE TO THIS ISSUE. A TWO-YEAR LOT HISTORY REVIEW WAS CONDUCTED AND FOUND NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT NUMBER. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 11 COMPLAINTS, REGARDING 17 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME 513,645 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 0.00003 CONMED ENCOURAGES THE INSPECTION OF ALL MEDICAL EQUIPMENT, LABELING AND PACKAGING PRIOR TO USE. 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, TUBE SET, SMOKE EVAC, LAPAROSCOPIC, CATALOG # 60-6810-001, LOT 145054, FOR A POSSIBLE INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH ANY PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION IN (B)(4). DUE TO THE POTENTIAL SEVERITY OF A POSSIBLE 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
    1089454 TUBE SET, SMOKE EVAC, LAPAROSCOPIC APPARATUS, EXHAUST, SURGICAL FYD CONSOLIDATED MEDICAL EQUIPMENT 145054

    Patients

    Seq Age Sex Outcome Treatment
    1