BEUDAMED
    FDA Adverse Event Other Summary report: N

    TYDINGS TONSIL SNARE, 7 3/8", 12 SNARE WIRES, 25 G

    MDR report key: 1073942 · Received July 7, 2008

    Report

    Report Number
    2430952-2008-00023
    Event Type
    Other
    Date Received
    July 7, 2008
    Date of Event
    June 17, 2008
    Report Date
    July 7, 2008
    Product Code
    KBZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. INTEGRA LIFESCIENCES CORPORATION IS FILING ON BEHALF OF THE INITIAL DISTRIBUTOR J. JAMMER SURGICAL INSTRUMENTS.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTS THAT THE TONSIL SNARE FAILED TO CUT THROUGH TISSUE AND RELEASE, NECESSITATING THE SURGEON TO REMOVE ADDITIONAL TISSUE TO FREE THE SNARE AND TONSIL TISSUE. THE SNARE PUSH ROD THAT IS ATTACHED TO THE MOVABLE HANDLE, JUMPED OUT OF THE CHANNEL AND JAMMED, PREVENTING THE SNARE CONTRACTION AROUND TONSIL. THE SURGERY TECHNICIAN HAD TO REMOVE THE THUMBSCREW TO RESET THE SNARE. IT APPEARS THAT THE DISTAL CHANNEL IS BENT. THE PHYSICIAN WAS CONCERNED ABOUT WHERE THE SNARE WAS POSITIONED, TOO CLOSE TO CAROTID ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYDINGS TONSIL SNARE, 7 3/8", 12 SNARE WIRES, 25 G JARIT THROAT/LARYNGEAL KBZ

    Patients

    Seq Age Sex Outcome Treatment
    1