BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCINTILLANT SURGICAL LIGHT

    MDR report key: 17318248 · Received July 13, 2023

    Report

    Report Number
    3005977121-2023-00002
    Event Type
    Malfunction
    Date Received
    July 13, 2023
    Date of Event
    June 8, 2023
    Report Date
    July 13, 2023
    Manufacturer
    ENGINEERED MEDICAL SOLUTIONS CO. LLC DBA BIHLERMED
    Product Code
    FTD
    UDI-DI
    10865082000143
    PMA / PMN Number
    K133425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE LIGHT COULD NOT BE REQUESTED BACK BECAUSE THE MANUFACTURER DOES NOT ACCEPT BACK CONTAMINATED DEVICES FOR EVALUATION. FOLLOW UP QUESTIONS WERE ASKED TO THE COMPLAINANT TO ASK FOR ADDITIONAL INFORMATION AND IF THERE WERE ANY PHOTOGRAPHS. THE RESPONSE RECEIVED DID NOT PROVIDE PHOTOGRAPHS OR ANY ADDITIONAL INFORMATION. THE DHR WAS REVIEWED FOR LOT 11541. NO INDICATIONS LEADING TO AN INSECURE LENS WERE FOUND. IT IS NOTED THAT THE REPORTER STATED THAT THE LIGHT WAS CONTINUED TO BE USED WITHOUT THE TIP. THIS IS AGAINST THE WARNINGS PROVIDED IN THE IFU. WARNING #1 STATES "INSPECT THE SCINTILLANT® DUAL TIP LIGHT PRIOR TO USE TO ENSURE PROPER FUNCTION AND WORKING CONDITION. DO NOT USE A DEVICE THAT IS DAMAGED." WITHOUT PICTURES OR A DEVICE TO EXAMINE, IT IS NOT POSSIBLE TO DETERMINE THE EXACT CAUSE OF LENS DISLODGEMENT. DURING ASSEMBLY, THE LENS IS SECURED TO THE STAINLESS STEEL TUBE IN A MANUAL HAND FIXTURE FOR SWAGING. THIS STEP IS 100% VISUALLY INSPECTED. IT IS NOT POSSIBLE FOR THIS LENS TO BE DISCONNECTED FROM THE DEVICE WITHOUT EXCESSIVE FORCE. WARNING #4 IN THE IFU STATES THAT "EXCESSIVE FORCE ON THE WIRES AND LIGHT TIPS COULD CAUSE THE DEVICE TO MALFUNCTION. CARE SHOULD BE TAKEN WHEN HANDLING THE DEVICE AND MANIPULATING THE TIPS INTO THE DESIRED LOCATIONS." IN PREVIOUS EVENTS WHERE THE LENS WAS DETACHED FOR THIS PRODUCT, AND PICTURES OR A RETURNED PRODUCT WAS EVALUATED, THERE WERE SIGNS OF EXCESSIVE FORCE AND MISUSE OF THE SURGICAL LIGHT.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA THE DISTRIBUTOR REGARDING A PATIENT UNDERGOING L2/3/4/5 OLIF AT LEVELS L2/3/4/5 FOR DEGENERATIVE SCOLIOSIS. IT WAS REPORTED THAT THE TIP OF THE BENT TIP FELL OUT WHEN ATTEMPTING TO REPLACE THE RADIANCE WITH THE RETRACTOR BLADE AFTER THE RETRACTOR WAS PLACED ON L4/5. THE PHYSICIAN NOTICED IT AND REMOVED IT. IT WAS USED WITHOUT A TIP. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312862 SCINTILLANT SURGICAL LIGHT SURGICAL LAMP FTD ENGINEERED MEDICAL SOLUTIONS CO. LLC DBA BIHLERMED 2762-01-0003 11541 10865082000143

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown