BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCINTILLANT SURGICAL LIGHT

    MDR report key: 15594711 · Received October 13, 2022

    Report

    Report Number
    3005977121-2022-00002
    Event Type
    Malfunction
    Date Received
    October 13, 2022
    Date of Event
    September 15, 2022
    Report Date
    October 13, 2022
    Manufacturer
    ENGINEERED MEDICAL SOLUTIONS CO. LLC DBA BIHLERMED
    Product Code
    FTD
    UDI-DI
    10865082000150
    PMA / PMN Number
    K133425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE LIGHT COULD NOT BE REQUESTED BACK BECAUSE IT WAS DISCARDED. FOLLOW UP QUESTIONS WERE ASKED TO THE COMPLAINANT TO CLARIFY HOW THE LIGHT WAS USED DURING THE PROCEDURE. RESPONSES WERE RECEIVED ON 10/07/22, BUT THE RESPONSES DID NOT INCLUDE PICTURES AND DID NOT HELP WITH THE INVESTIGATION. THE DHR WAS REVIEWED FOR LOT 11440. NO INDICATIONS LEADING TO AN INSECURE LENS WERE FOUND. WITHOUT PICTURES OR A DEVICE TO EXAMINE IT IS NOT POSSIBLE TO DETERMINE THE EXACT CAUSE OF LENS DISLODGEMENT. IT SHOULD ALSO NOT BE POSSIBLE TO REATTACH A LENS ONCE DISCONNECTED. 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 (B)(4).

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA THE DISTRIBUTOR REGARDING A PATIENT HAVING SPINAL THERAPY FOR AN INDICATION OF L4 COMPRESSION. IT WAS REPORTED THAT THE DEVICE WAS INSTALLED IN A RETRACTOR AND PREPARED FOR USE. HOWEVER, THE DEVICE WAS REMOVED PRIOR TO USE AND THE LENS AT THE TIP OF THE LIGHT CAME OFF. THE COMPLAINANT STATED THAT THE LENS COULD BE REATTACHED, BUT DID NOT USE THE DEVICE AFTER REATTACHING THE LENS IN CASE IT DISLOCATED AGAIN. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2575298 SCINTILLANT SURGICAL LIGHT SURGICAL LAMP FTD ENGINEERED MEDICAL SOLUTIONS CO. LLC DBA BIHLERMED 2762-01-0004 11440 10865082000150

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown