BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERNUM SAW HANDPIECE

    MDR report key: 7674841 · Received July 10, 2018

    Report

    Report Number
    1017294-2018-00105
    Event Type
    Malfunction
    Date Received
    July 10, 2018
    Date of Event
    June 20, 2018
    Report Date
    July 10, 2018
    Manufacturer
    CONMED CORPORATION
    Product Code
    KFK
    PMA / PMN Number
    K801737
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY THE CONMED REPRESENTATIVE THAT 00505900500, STERNUM SAW HANDPIECE CONTINUED TO RUN AFTER USE. THERE WAS NO PATIENT/USER INJURY OR SURGICAL DELAY WITH THIS REPORTED ISSUE AND THE PROCEDURE WAS COMPLETED AS PLANNED. THE EVALUATION FOUND THAT THE ROLLER CAUSED THE DEVICE TO RUN WITHOUT TRIGGER ACTIVATION. PARTS WERE REPLACED AS NEEDED AND PREVENTATIVE MAINTENANCE WAS PERFORMED. THE SERVICE HISTORY WAS REVIEWED AND NO OTHER COMPLAINTS WERE FOUND. A DEVICE HISTORY REVIEW WAS NOT DONE SINCE THE DEVICE HAS BEEN IN THE FIELD FOR MORE THEN 12 MONTHS. PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING; CAUTIONS: HANDLE ALL EQUIPMENT CAREFULLY. SHOULD A HANDPIECE OR ATTACHMENT BE DROPPED OR DAMAGED IN ANY WAY, RETURN IT IMMEDIATELY FOR SERVICE. CONTINUALLY CHECK ALL PARTS OF THE INSTRUMENT OR ITS ATTACHMENTS FOR OVERHEATING. IF OVERHEATING IS NOTICED, DISCONTINUE USE AND RETURN THE EQUIPMENT FOR SERVICE. WARNINGS: PRIOR TO EACH USE, PERFORM THE FOLLOWING: A. INSPECT ALL EQUIPMENT FOR PROPER OPERATION. B. ENSURE ALL ATTACHMENTS, ACCESSORIES, AND HOSES ARE CORRECTLY AND COMPLETELY ATTACHED TO THE HANDPIECE. C. INSPECT PNEUMATIC HOSES FOR SIGNS OF WEAR OR DAMAGE PRIOR TO USE. DISCONTINUE USE AND REPLACE IMMEDIATELY IF ANY SIGNS OF WEAR OR DAMAGE ARE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CONMED REPRESENTATIVE THAT 00505900500, STERNUM SAW HANDPIECE CONTINUED TO RUN AFTER USE. THERE WAS NO PATIENT/USER INJURY OR SURGICAL DELAY WITH THIS REPORTED ISSUE AND THE PROCEDURE WAS COMPLETED AS PLANNED. THIS REPORT IS BEING RAISED ON THE BASIS OF A DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518458 STERNUM SAW HANDPIECE PNEUMATIC SURGICAL SAW KFK CONMED CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1