BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRAZIER

    MDR report key: 22902178 · Received August 27, 2025

    Report

    Report Number
    1320894-2025-00214
    Event Type
    Malfunction
    Date Received
    August 27, 2025
    Date of Event
    June 26, 2025
    Report Date
    September 30, 2025
    Manufacturer
    CONMED UTICA
    Product Code
    GCX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION AND REVIEW. HOWEVER, THE COMPLAINT INVESTIGATION IS NOT COMPLETE AT THIS TIME. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE COMPLAINT INVESTIGATION. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 0

    NEITHER THE DEVICE NOR PHOTOGRAPHIC EVIDENCE WAS PROVIDED. THEREFORE, THE REPORTED EVENT CANNOT BE VERIFIED. 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 TWO COMPLAINTS, REGARDING TWO DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME(B)(4) 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). WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDWATCH REPORT: MW5173319 ON 13AUG2025. THE CURRENT COMPLAINT DATABASE HAS BEEN RESEARCHED FOR THIS EVENT AND THERE WERE NO FINDINGS. THE REPORT WAS FOUND TO BE WRITTEN AGAINST 0033080, SURGICAL SUCTION INSTRUMENT, 8FR W/CONTROL VENT & OBTURATOR, DEVICE. IT WAS STATED THAT THE DEVICE WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2025. THE REPORT STATED, ¿DURING THE SURGERY THE END PIECE OF DISPOSABLE FRAZIER SUCTION BROKE OFF (ABOUT 1 CM IN SIZE) REF#: 0033080 THE X RAY FOR FOREIGN BODY WAS PERFORMED AND DR. (B)(6) FROM RADIOLOGY CONFIRMED THE X RAY RESULTS WERE CLEAR AND NO FOREIGN BODY NOTED IN THE PATIENT.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Description of Event or Problem · 0

    THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDWATCH REPORT MW5173319 ON 13AUG25. THE CURRENT COMPLAINT DATABASE HAS BEEN RESEARCHED FOR THIS EVENT AND THERE WERE NO FINDINGS. THE REPORT WAS FOUND TO BE WRITTEN AGAINST 0033080, SURGICAL SUCTION INSTRUMENT, 8FR W/CONTROL VENT & OBTURATOR, DEVICE. IT WAS STATED THAT THE DEVICE WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2025. THE REPORT STATED, ¿DURING THE SURGERY THE END PIECE OF DISPOSABLE FRAZIER SUCTION BROKE OFF (ABOUT 1 CM IN SIZE) REF #0033080 THE X RAY FOR FOREIGN BODY WAS PERFORMED AND DR. (B)(6) FROM RADIOLOGY CONFIRMED THE X RAY RESULTS WERE CLEAR AND NO FOREIGN BODY NOTED IN THE PATIENT.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. 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
    1380474 FRAZIER APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED GCX CONMED UTICA 202409121

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Male