BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEROYAL

    MDR report key: 3850365 · Received March 18, 2014

    Report

    Report Number
    2320762-2014-00008
    Event Type
    Malfunction
    Date Received
    March 18, 2014
    Date of Event
    February 7, 2014
    Report Date
    February 18, 2014
    Manufacturer
    I.C. MEDICAL, INC
    Product Code
    FYD
    PMA / PMN Number
    K932230
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MEDICAL CENTER REPORTED THAT THE WHITE PLASTIC ON THE DISTAL TIP NEAR THE INSERTION POINT OF THE BLADE BROKE INTO PIECES DURING THE CASE. THE ISSUE DID NOT AFFECT THE FUNCTION OF THE DEVICE BUT CAUSED A PT SAFETY CONCERN IF THE MATERIAL WOULD HAVE BEEN INTRODUCED INTO THE PT AND NOT DETECTED. DEROYAL: THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE REPORTED ISSUE WAS SENT TO DEROYAL'S VENDOR, I.C. MEDICAL, FOR FURTHER INVESTIGATION TO BE COMPLETED. THE INVESTIGATION INTO THE ROOT CAUSE IS IN PROCESS.

    Description of Event or Problem · 1

    THE MEDICAL CENTER REPORTED THAT THE WHITE PLASTIC ON THE DISTAL TIP NEAR THE INSERTION POINT OF THE BLADE BROKE INTO PIECES DURING THE CASE. THE ISSUE DID NOT AFFECT THE FUNCTION OF THE DEVICE BUT CAUSED A PT SAFETY CONCERN IF THE MATERIAL WOULD HAVE BEEN INTRODUCED INTO THE PT AND NOT DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161142 DEROYAL APPARATUS, EXHAUST, SURGICAL FYD I.C. MEDICAL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1