BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCINTILLANT SURGICAL LIGHT

    MDR report key: 17119404 · Received June 13, 2023

    Report

    Report Number
    3005977121-2023-00001
    Event Type
    Malfunction
    Date Received
    June 13, 2023
    Date of Event
    May 15, 2023
    Report Date
    June 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
    TN, US
    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 CLARIFY WHAT PART OF THE LIGHT WAS DETACHED AND IF THERE WERE ANY PHOTOGRAPHS. THE RESPONSE RECEIVED DID NOT PROVIDE PHOTOGRAPHS OR ANY ADDITIONAL INFORMATION. THE DHR WAS REVIEWED FOR LOT 11702. 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 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 HEALTHCARE PROVIDER (HCP) VIA THE DISTRIBUTOR REGARDING A PATIENT HAVING MICRODISCECTOMY FOR UNKNOWN INDICATION. IT WAS REPORTED THAT THE TIP OF THE LIGHT SOURCE FELL OFF. 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
    206913 SCINTILLANT SURGICAL LIGHT SURGICAL LAMP FTD ENGINEERED MEDICAL SOLUTIONS CO. LLC DBA BIHLERMED 2762-01-0003 11702 10865082000143

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown