BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRAZIER SUCTION

    MDR report key: 22612778 · Received July 25, 2025

    Report

    Report Number
    MW5173319
    Event Type
    Malfunction
    Date Received
    July 25, 2025
    Date of Event
    June 26, 2025
    Report Date
    July 22, 2025
    Manufacturer
    CONMED CORPORATION
    Product Code
    GCX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    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. (B)(6) IS A 24 YEAR OLD MALE KNOWN TO THE OMFS SERVICE WITH TRISOMY 21 WHO PRESENTED WITH MOTHER COMPLAINING OF JAW PAIN AND REFERRED FOR EVALUATION OF IMPACTED TEETH AND ASSOCIATED CYST OF THE LOWER JAW. DUE TO THE INVASIVE AND EXTENSIVE NATURE OF THE PROCEDURE IT WAS DECIDED TO PROCEED WITH TREATMENT IN THE OPERATING ROOM UNDER GENERAL ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040330 FRAZIER SUCTION APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED GCX CONMED CORPORATION 0033080 202409121

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Male