BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRAZR SUCTN INSTR C/W CONTRL VENT & OBTU

    MDR report key: 17443463 · Received August 2, 2023

    Report

    Report Number
    1320894-2023-00152
    Event Type
    Malfunction
    Date Received
    August 2, 2023
    Report Date
    August 2, 2023
    Manufacturer
    CONMED UTICA
    Product Code
    GCX
    UDI-DI
    30653405000116
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED ONE 0033080 IN ORIGINAL PACKAGING. LOT NUMBER WAS VERIFIED. PERFORMED A VISUAL INSPECTION, THE DEVICE WAS ENCROACHING THE SEAL. PERFORMED A FUNCTIONAL INSPECTION, THE DEVICES WERE DYE LEAK TESTED WHICH INDICATED THAT THE PACKAGING HAD AN INSUFFICIENT HEAT SEAL. ROOT CAUSE CANNOT BE DETERMINED, HOWEVER, BASED UPON EVALUATION OF THE DEVICE; A POSSIBLE CAUSE OF THIS EVENT COULD BE THAT THE DEVICE WAS ENCROACHING THE SEAL. 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 35 COMPLAINTS, REGARDING 75 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME 3,807,390 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. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 0033080, FOR AN INSUFFICIENT HEATSEAL. THE DEVICE WAS ENCROACHING THE SEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1467433 FRAZR SUCTN INSTR C/W CONTRL VENT & OBTU APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED GCX CONMED UTICA 202205311 30653405000116

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown