BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRAZIER INSTR 8 FRENCH

    MDR report key: 9973654 · Received April 17, 2020

    Report

    Report Number
    1320894-2020-00188
    Event Type
    Malfunction
    Date Received
    April 17, 2020
    Report Date
    May 20, 2020
    Manufacturer
    CONMED CORPORATION
    Product Code
    GCX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED ONE 0033080 IN UNOPENED ORIGINAL PACKAGING. LOT NUMBER WAS VERIFIED. PERFORMED A VISUAL INSPECTION OF THE DEVICE, THERE WERE NO OBVIOUS SIGNS OF A BREACH. DYE LEAK TESTING FOUND THAT THE PACKAGING HAD AN INSUFFICIENT HEATSEAL. 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 WERE FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. A 2 YEAR LOT HISTORY REVIEW WAS CONDUCTED AND FOUND THIS IS THE ONLY EVENT WITH A QUANTITY OF 2 UNITS FOR THIS LOT NUMBER AND FAILURE MODE. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN (B)(4) COMPLAINTS REGARDING 87 DEVICES FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THE SAME TIME FRAME 19,213,321 DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED, THE RATE OF FAILURE WOULD BE (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING; CONMED ENCOURAGES THE INSPECTION AND/OR TEST OF ALL MEDICAL EQUIPMENT PRIOR TO USE. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 1

    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 IN (B)(4) REJECTED 0033080, FRAZIER SUCTION W CONTROL VENT, DUE TO AN "INSUFFICIENT HEAT SEAL". IN THIS INSTANCE, THERE WAS NO PATIENT INVOLVEMENT AS THE PACKAGING ANOMALY WAS DISCOVERED DURING INCOMING INSPECTION PRIOR TO DISTRIBUTION TO AN END-USER. THIS REPORT IS BEING RAISED BASED ON DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437689 FRAZIER INSTR 8 FRENCH SUCTION INSTRUMENT GCX CONMED CORPORATION 201810151

    Patients

    Seq Age Sex Outcome Treatment
    1