BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    150 MICRON TFL BALL TIP SINGLE USE FIBER

    MDR report key: 13915390 · Received March 26, 2022

    Report

    Report Number
    3003790304-2022-00045
    Event Type
    Malfunction
    Date Received
    March 26, 2022
    Date of Event
    February 22, 2022
    Report Date
    June 8, 2022
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    GEX
    PMA / PMN Number
    K183647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IN A FOLLOW UP COMMUNICATION WITH THE CUSTOMER, IT WAS CONVEYED THAT THE URETEROSCOPE USED WITH THE FIBER WAS NOT AN OLYMPUS SCOPE. CUSTOMER CONVEYED THAT THE SCOPE IS A WOLF RIGID URETEROSCOPE (THIRD PARTY SCOPE). THE SUBJECT DEVICE WAS RECEIVED FOR EVALUATION, HOWEVER, DEVICE EVALUATION IS STILL PENDING. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND DEVICE EVALUATION. THE SUBJECT DEVICE WAS RETURNED IN A SEALED PLASTIC PACKAGE. THE FIBER WAS INSIDE THE OPENED ORIGINAL TYVEK PACKAGING. THE PACKAGING CONFIRMED THE LOT NUMBER WAS KR112279. THE FAILURE MODE OF THE FIBER BREAKAGE WAS CONFIRMED VISUALLY WITH THE DISTAL END OF THE FIBER SHOWING NO EXPOSED FIBER AND A SHEARED END. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE OF THE MALFUNCTION CANNOT BE SPECIFIED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A CALCULI FRAGMENTATION PROCEDURE, THE FIBER BROKE IN THE URETEROSCOPE. THE FIBER AND THE URETEROSCOPE WERE REPLACED. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052978 150 MICRON TFL BALL TIP SINGLE USE FIBER 150 MICRON TFL BALL TIP SINGLE USE FIBER GEX GYRUS ACMI, INC TFL-FBX150BS KR112279

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown WOLF RIGID URETEROSCOPE