BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILED TRIPLE TUSM

    MDR report key: 15216330 · Received August 12, 2022

    Report

    Report Number
    3007143268-2022-00019
    Event Type
    Malfunction
    Date Received
    August 12, 2022
    Date of Event
    July 27, 2022
    Report Date
    September 1, 2022
    Manufacturer
    TRUMPF MEDIZIN SYSTEME GMBH + CO. KG
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS CHECKED AND IT WAS IDENTIFIED THAT THE MOON CLIP WAS WORE CAUSING THE GROOVE IT SITS IN TO RAMP AND LET THE BRACKET MOVE DOWN A BIT. THE BRACKET AND CLIP WERE REPLACED AND DEVICE FUNCTIONED AS DESIGNED. FURTHER INVESTIGATION SHOULD CONFIRM THE ROOT CAUSE. INVESTIGATION RESULTS WILL BE PROVIDED WITHIN A FINAL REPORT IF NEW INFORMATION WILL BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE ILED LIGHT SYSTEM WAS INSPECTED BY A FIELD SERVICE TECHNICIAN. IT WAS IDENTIFIED THAT THE LOCKING SEGMENT (CRESCENT KEY) WORE CAUSING THE GROOVE IT SITS IN TO RAMP AND LET THE BRACKET MOVE DOWN A BIT. BASED ON OUR PRODUCT HISTORY RECORDS NO PREVENTIVE MAINTENANCE IS NOTED. THE DEVICE IS 8 YEARS OLD AND PREVENTATIVE MAINTENANCE IS REQUIRED EVERY 2 YEARS. REGARDING THE MAINTENANCE PROTOCOL THE MOON CLIP NEEDS TO BE CHECKED AND THE THICKNESS SHOULD BE MEASURED. THE ROOT CAUSE FOR THE EVENT WAS TRACED TO NOT FOLLOWING THE INSTRUCTIONS FOR USE, MISSING REGULARLY PREVENTIVE MAINTENANCE. THE LIGHT SYSTEM WAS REPAIRED AND CHECKED FOR FUNCTIONALITY. BASED ON THIS, NO FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    IT IS ALLEGED THAT THE DISPLAY MONITOR BRACKET WAS DROPPING DOWN SLIGHTLY. NO HARM OR SIGNIFICANT IMPACT TO THE SURGICAL PROCEDURE WAS REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT (B)(4).

    Description of Event or Problem · 0

    IT WAS ALLEGED THAT THE DISPLAY MONITOR BRACKET WAS DROPPING DOWN SLIGHTLY. NO HARM OR SIGNIFICANT IMPACT TO THE SURGICAL PROCEDURE WAS REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1931040 ILED TRIPLE TUSM SURGICAL LIGHT FSY TRUMPF MEDIZIN SYSTEME GMBH + CO. KG 1565161

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown