BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASPEN SURGICAL ALC PLUS LIGHT HANDLE COVER, NON-STERILE

    MDR report key: 10678616 · Received October 14, 2020

    Report

    Report Number
    1836161-2020-00051
    Event Type
    Malfunction
    Date Received
    October 14, 2020
    Date of Event
    September 18, 2020
    Report Date
    September 21, 2020
    Manufacturer
    ASPEN SURGICAL PRODUCTS, CALEDONIA
    Product Code
    FTA
    PMA / PMN Number
    K020304
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ASPEN SURGICAL RECEIVED A REPORT FROM THE END USER INDICATING THAT A LIGHT HANDLE COVER FELL DURING A PROCEDURE. NO INJURY/DEATH WAS REPORTED. NO SAMPLE OR LOT NUMBER WERE AVAILABLE FOR EVALUATION. ALTHOUGH NO SAMPLES WERE RETURNED, ASPEN SURGICAL CONFIRMED PRODUCT SPECIFICATION BY TESTING FOR DIMENSIONAL ACCURACY ON IN-HOUSE PRODUCT WITH NO ISSUES DISCOVERED. FURTHER RESEARCH FOUND THAT END USERS WERE EXPERIENCING ISSUES WITH THE ALC COVERS USING TRUMPF ILED7 LIGHTS WITH AN SLC HANDLE. ASPEN'S PRODUCT BROCHURE FOR THE LT-ALC01 STATE THAT IT IS FOR USE WITH TRUMPF ALC SURGICAL LIGHT HANDLE MODELS: TRULIGHT 5000 AND ILED 3/5. PER THIS LITERATURE, THE ALC IS NOT COMPATIBLE WITH THE ILED7 SURGICAL LIGHT. DUE TO THIS INCOMPATIBILITY WITH THE ILED7, THIS PREVENTS THE LT-ALC01 COVER FROM FULLY ENGAGING THE SNAP BUTTON ON THE SLC CAUSING THE HANDLE TO BE INCORRECTLY SECURED. THEREFORE, THE CAUSE CAN BE ATTRIBUTED TO OFF LABEL USE BY THE END USER. LIGHT HANDLES IDENTIFIED WERE USED ON A SURGICAL LIGHT MODEL FOR WHICH THEY WERE NOT DESIGNED OR CLAIMED BY ASPEN AS COMPATIBLE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    ASPEN SURGICAL RECEIVED A REPORT FROM THE END USER INDICATING THAT A LIGHT HANDLE COVER FELL DURING A PROCEDURE. NO INJURY/DEATH WAS REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1146352 ASPEN SURGICAL ALC PLUS LIGHT HANDLE COVER, NON-STERILE LIGHT HANDLE FTA ASPEN SURGICAL PRODUCTS, CALEDONIA LT-ALC01NS

    Patients

    Seq Age Sex Outcome Treatment
    1