BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARBON SURGICAL BLADES 15

    MDR report key: 842442 · Received April 13, 2007

    Report

    Report Number
    2523190-2007-00001
    Event Type
    Malfunction
    Date Received
    April 13, 2007
    Report Date
    April 13, 2007
    Manufacturer
    KAI INDUSTRIES CO, LTD
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A PROCEDURE, THE INSTRUMENT BLADE BROKE. THE BROKEN BLADE WAS REMOVED AND NO PT INJURY IS REPORTED. THE SURGERY WAS COMPLETED AS SCHEDULED. ADD'L INFO PROVIDED: A CALL TO THE USER FACILITY WAS PLACED CONFIRMING THAT THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARBON SURGICAL BLADES 15 SURGICAL INSTRUMENT GFA KAI INDUSTRIES CO, LTD * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *