BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR HOSE, 10'

    MDR report key: 1082716 · Received July 23, 2008

    Report

    Report Number
    1017294-2008-00261
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    June 24, 2008
    Report Date
    June 24, 2008
    Manufacturer
    CONMED LINVATEC
    Product Code
    GET
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: CONMED LINVATEC RECEIVED THE DEVICE FOR EVAL AND CONFIRMED THE REPORTED PROBLEM THAT THE OUTER HOSE BURST AT THE COUPLING END. THIS TYPE OF FAILURE CAN OCCUR WITH EXTENDED USE OF THE DEVICE. THE HANDPIECE INSTRUCTION MANUAL INFORMS USERS TO INSPECT AND OPERATE THE SYSTEM FOR PROPER FUNCTIONING PRIOR TO USE. THE CUSTOMER WILL BE SENT ADDITIONAL INFO ON THE CARE AND HANDLING OF THIS DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THIS HOSE IN A PODIATRY PROCEDURE, IT BURST INTO PIECES AT THE COUPLING END. THE USER REPORTED THAT NO PIECES OF HOSE ENTERED THE SURGICAL SITE OR STERILE FIELD. THERE WAS NO REPORT OF SERIOUS INJURY OR SURGICAL DELAY WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIR HOSE, 10' HOSE GET CONMED LINVATEC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK