BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KLF-001-600 .6MM FIBER

    MDR report key: 17083624 · Received June 7, 2023

    Report

    Report Number
    3024753061-2023-00001
    Event Type
    Malfunction
    Date Received
    June 7, 2023
    Date of Event
    April 11, 2023
    Report Date
    June 7, 2023
    Manufacturer
    OPTICAL INTEGRITY
    Product Code
    GEX
    UDI-DI
    00860004755913
    PMA / PMN Number
    K022338
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE INVESTIGATION IS COMPLETED. IT WAS OBSERVED THAT THERE WAS A MECHANICAL BREAK AT THE DISTAL TIP OF THE FIBER. THE AREA OF BREAKAGE INDICATED A LONGITUDINAL FORCE WAS APPLIED TO THE TIP. IT IS SUSPECTED THAT DEVICE WAS MISHANDLED BY THE USER. PER DEVICE IFU, UNDER THE "PRECAUTION" SECTION, IT IS STATED "DO NOT BEND FIBER AT SHARP ANGLES." AND "CARE SHOULD BE EXERCISED WITH THE GLASS TIP TO AVOID SEVERE IMPACTS OR SIDE STRESSES WHICH MAY FRACTURE THE TIP." PLEASE NOTE, THIS IS INNOVOYCE'S FIRST ELECTRONIC REPORT, AND IT WAS DELAYED DUE TO ISSUES WITH THE ESG PORTAL SIGNING CERTIFICATE VERIFICATION PROCESS. FDA'S MDR POLICY WAS NOTIFIED.

    Description of Event or Problem · 0

    INNOVOYCE RECEIVED A CUSTOMER REPORT OF A PRODUCT PROBLEM WITH THE .600 KTP FIBER, WHERE THE FIBER "BROKE OFF INSIDE A PATIENT" DURING A ROUTINE PROCEDURE. THE PHYSICIAN RETRIEVED THE PIECE OF FIBER FROM THE PATIENT AND THE PATIENT WAS INTUBATED AS A PRECAUTION. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1367944 KLF-001-600 .6MM FIBER INNOVOYCE LASER FIBER GEX OPTICAL INTEGRITY KLF-001-600 M19806 00860004755913

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention