BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCINTILLANT SURGICAL LIGHT

    MDR report key: 12260056 · Received August 2, 2021

    Report

    Report Number
    3005977121-2021-00001
    Event Type
    Malfunction
    Date Received
    August 2, 2021
    Date of Event
    June 28, 2021
    Report Date
    June 29, 2021
    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 PRODUCT WAS RECEIVED BACK ON 10/06/21. THE ONE END OF THE STAINLESS STEEL LIGHT TIP WAS DEFORMED AND FLATTENED AGAINST THE LED. IT WAS CONFIRMED THAT THE CLEAR LENS WAS NO LONGER ATTACHED. DURING ASSEMBLY, THE LENS IS SECURED TO THE STAINLESS STEEL TUBE IN A MANUAL HAND FIXTURE FOR SWAGING. THIS STEP IS 100% VISUALLY INSPECTED. THE DUAL TIP LIGHTS ARE PACKAGED IN A PLASTIC TRAY WITH A RETAINER COMPONENT TO ADD FURTHER PROTECTION TO THE DEVICE IN TRANSPORT. THE DEVICE IS INTENDED TO BE USED WITH A MEDTRONIC RETRACTOR AND SHOULD NOT BE SUBJECTED TO THE TYPE OF FORCE THAT WOULD RESULT IN THE FOUND DEFORMATION. 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." ENGINEERING HAS CONCLUDED USER ERROR OR MISUSE LED TO THE MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LENS OF THE SURGICAL LIGHT BROKE OFF. THERE WAS NO PATIENT INVOLVED WITH THE EVENT.

    Additional Manufacturer Narrative · 1

    THE LIGHT WAS REQUESTED TO BE RETURNED. PICTURES AND ADDITIONAL INFORMATION WAS ALSO REQUESTED. INVESTIGATION IS PENDING UNTIL MORE INFORMATION CAN BE RECEIVED. REPORT WAS NOT SUBMITTED WITHIN THE 30 DAY DEADLINE DUE TO TECHNICAL CHALLENGES WITH WEBTRADER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LENS OF THE SURGICAL LIGHT BROKE OFF. THERE WAS NO PATIENT INVOLVED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1161127 SCINTILLANT SURGICAL LIGHT SURGICAL LIGHT FTD ENGINEERED MEDICAL SOLUTIONS CO. LLC DBA BIHLERMED 2762-01-0004 11211 10865082000150

    Patients

    Seq Age Sex Outcome Treatment
    1