BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YAG LASER FIBER, SINGLE, 5FR, 600 UM CORE

    MDR report key: 31073 · Received March 11, 1996

    Report

    Report Number
    MW1008574
    Event Type
    Malfunction
    Date Received
    March 11, 1996
    Date of Event
    February 7, 1996
    Report Date
    February 28, 1996
    Manufacturer
    HERAEUS SURGICAL, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HEARAEUS SURGICAL, 575 COTTONWOOD DR, MILIPITAS, CA 95035. THIS LETTER IS IN RESPONSE TO YOUR LETTER DATED 3/11/96, REFERENCING THE ABOVE ACCESS NUMBER AND MEDWATCH REPORT RECEIVED FROM A USER-FACILITY. ALTHOUGH OUR INVESTIGATION OF THIS INCIDENT IS NOT COMPLETE, OUR CURRENT DETERMINATION IS THAT THIS EVENT IS NOT REPORTABLE UNDER THE MEDWATCH REPORTING PROGRAM. THE CUSTOMER WAS CONTACTED IN AN ATTEMPT TO OBTAIN FURTHER INFO. NO INJURIES WERE REPORTED AS A RESULT OF THIS INCIDENT. IT WAS DETERMINED THAT THE LASER SYSTEM USED DURING THE INCIDENT WAS A LASER SONICS DEVICE, HOWEVER THE EXACT MODEL NUMBER WAS UNAVAILABLE. THE CUSTOMER REPORTED THAT SUBSEQUENT TO THE INCIDENT, THE LASER SYSTEM WAS SERVICED BY AN INDEPENDENT CONTRACTOR WHO DETERMINED THAT THE LASER SYSTEM WAS FULLY OPERATIONAL AND WITHIN SPEC. HERAEUS SURGICAL REQUESTED RETURN OF THE LASERSONCIS G56D LASER FIBER FOR EVALUATION. TO DATE, THIS FIBER HAS NOT BEEN RECEIVED. IF EVALUATION OF THIS FIBER CHANGES OUR MDR REPORTING DETERMINATION OF THIS INCIDENT, ADD'L INFO WILL BE SENT TO FDA AT THAT TIME. IF YOU HAVE ADD'L QUESTIONS, PLEASE CONTACT ME DIRECTLY AT: (408) 954-4208.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 YAG LASER FIBER, SINGLE, 5FR, 600 UM CORE LASER FIBER GEX HERAEUS SURGICAL, INC. 045G6

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR