BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SNARE WIRE SIZE 8X4-1/2 PKG/12

    MDR report key: 4171097 · Received July 15, 2014

    Report

    Report Number
    2523190-2014-00050
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 24, 2014
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    KBZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTED SNARE WIRES BROKE DURING A PROCEDURE. NO PATIENT INJURY. (B)(6) 2014 CUSTOMER REPORTS 2 TONSIL SNARES BROKE WHILE IN USE, ONE FOR EACH TONSIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413543 SNARE WIRE SIZE 8X4-1/2 PKG/12 NA KBZ INTEGRA YORK, PA INC. 105-1307

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR