BEUDAMED
    FDA Adverse Event Summary report: N

    STANDARD 8FR FRAZIER WITH VENT

    MDR report key: 2026903 · Received March 22, 2011

    Report

    Report Number
    1320894-2011-00021
    Date Received
    March 22, 2011
    Report Date
    May 16, 2011
    Manufacturer
    CONMED CORPORATION
    Product Code
    JOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: THE INITIAL REPORT OF THIS INCIDENT LISTED FDA PRODUCT CODE OF JOL; WHEREAS, THE CORRECT FDA PRODUCT CODE IS BYY AS REPORTED ABOVE IN THIS REPORT. MANUFACTURER NARRATIVE: NO PRODUCT WAS RETURNED FOR EXAMINATION OR CONFIRMATION OF DEFECT OF SUSPECT CONMED PRODUCT. A REVIEW OF THE MANUFACTURING DOCUMENTS, FROM THE DHR/LHR, DEVICE HISTORY RECORD/LOT HISTORY RECORD, FOR LOT NUMBER, 1001069, HAS VERIFIED THE DEVICES WERE PRODUCED ACCORDING TO CURRENT AND APPROVED PROCEDURES AND MATERIAL SPECIFICATIONS. NON-CONFORMANCES REGARDING THE PRODUCT'S IDENTITY, QUALITY, SAFETY, EFFECTIVENESS OR PERFORMANCE WERE NOT IDENTIFIED DURING MANUFACTURE. A 24-MONTH REVIEW OF THE CUSTOMER COMPLAINT HISTORY FOR METAL OBJECT IN THE SUCTION TIP HAS SHOWN NO SIMILAR COMPLAINTS MAKING THIS AN ISOLATED INCIDENT. THE EVIDENCE SURROUNDING THIS COMPLAINT IS INCONCLUSIVE. IT IS UNKNOWN IF THE METAL FRAGMENT CAME FROM THIS DEVICE, AND NO DEVICE WAS KEPT FOR EXAMINATION AFTER THE SURGICAL PROCEDURE. NO ROOT CAUSES CAN BE CONFIRMED WITHOUT EXAMINATION OF THE PRODUCT. THE END-USER STATED THAT THERE WAS NO ISSUE IDENTIFIED WITH THE SUSPECT DEVICE AT THE TIME OF THE SURGERY AND THEREFORE THE DEVICE WAS DISCARDED. SINCE THERE IS NO TREND OF METAL FRAGMENTS FOUND IN THE TIP OF THESE SUCTION DEVICES, AND NO DEVICE WAS MADE AVAILABLE FOR EXAMINATION, THE INVESTIGATION CANNOT CONFIRM ANY MANUFACTURING DEFICIENCIES AT THIS TIME. A HHE, HEATH HAZARD EVALUATION, WAS CONDUCTED WHICH DETERMINED A VERY LOW RISK TO PATIENT SAFETY ASSOCIATED WITH A EVENT OF THIS NATURE. THE COMPLAINT INVESTIGATION HAS NOT IDENTIFIED ANY MANUFACTURING DEFECTS WITH THIS DEVICE; THEREFORE CORRECTIVE ACTION IS NOT RECOMMENDED AT THIS TIME. CONMED IS CONSIDERING THIS COMPLAINT CLOSED.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT BEING RETURNED TO CONMED CORPORATION. WHEN A QUALITY ENGINEERING INVESTIGATION IS COMPLETED A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE DISCARDED BY END-USER.

    Description of Event or Problem · 1

    IT WAS REPORTED, "ROUTINE MICRODISCECTOMY AND RECOVERY. ON ROUTINE POST-OPERATIVE FOLLOW-UP CT SCAN SMALL METAL OBJECT IDENTIFIED. ALL OTHER METAL SURGICAL EQUIPMENT EXAMINED FOR FAULTS OR ALTERED INTEGRITY INCLUDING DRILL CASING WITH NO FAULTS IDENTIFIED. DISPOSABLE SUCTION CATHETER WITH PLASTIC HANDLE AND MALLEABLE METAL TIP DISCARDED FOLLOWING PROCEDURE AS NO ISSUE IDENTIFIED AT TIME OF INCIDENT THEREFORE UNABLE TO BE RETRIEVED FOR EXAMINATION. DOCTOR HAS INDICATED TO PATIENT THAT FURTHER SURGERY IS NOT NECESSARY AT THIS TIME. PATIENT IS AWARE OF METAL FRAGMENT IN WOUND ALTHOUGH HAS NO ALTERED INTEGRITY OF THE WOUND OR DIMINISHED SURGICAL RECOVERY AS A RESULT. REPORT SOURCED FROM PRIVATE NURSE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STANDARD 8FR FRAZIER WITH VENT DISPOSABLE FRAZIER SUCTION INSTRUMENT JOL CONMED CORPORATION 1001069

    Patients

    Seq Age Sex Outcome Treatment
    1 Other