BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    150 MICRON TFL BALL TIP SINGLE USE FIBER

    MDR report key: 17235478 · Received June 30, 2023

    Report

    Report Number
    3003790304-2023-00254
    Event Type
    Malfunction
    Date Received
    June 30, 2023
    Date of Event
    May 30, 2023
    Report Date
    September 8, 2023
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    GEX
    PMA / PMN Number
    K183647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. 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 PROBABLE CAUSE OF THE FIBER FIRE AT THE CONNECTOR END COULD NOT BE DETERMINED. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: "ANY TAMPERING WITH THE LASER FIBER CONTACT CONNECTOR MAY CAUSE UNWANTED EMISSION OF LASER RADIATION. BEFORE PERFORMING ANY LASER EMISSION, MAKE SURE THAT THE PROBE IS INSERTED CORRECTLY. PAY ATTENTION TO THE FIRING DIRECTION." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    COMMUNICATION WITH THE CUSTOMER NOTED THAT THE REPORTED EVENT DID NOT AFFECT THE OUTCOME OF PROCEDURE , CUSTOMER STATED " ONLY SLOWED THE CASE DOWN ". NO ERRORS WERE OBSERVED AT THE TIME OF THE EVENT. OTHER DEVICE CONNECTED TO THE DEVICE WHEN THE FAILURE OCCURRED , CUSTOMER STATED "ANESTHESIA". THE SUBJECT DEVICE WAS RECEIVED AND EVALUATED. THE DEVICE WAS INSPECTED , NOTED THAT ONLY THE CONNECTOR PORTION OF THE FIBER WAS RETURNED. INSPECTION FOUND THE STRAIN RELIEF HAS SIGNS OF BURNING AND MELTING WITH A SMALL SECTION OF FIBER STICKING OUT OF THE STRAIN RELIEF. THE BURNING IS LIMITED TO THE STRAIN RELIEF AREA WITH THE REST OF THE CONNECTOR INTACT. THE PROXIMAL CAP IS ON. THE DEVICE WAS RETURNED TO ORIGINAL EQUIPMENT MANUFACTURER (OEM) FOR FURTHER EVALUATION . INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THE LASER FIBER CAUGHT ON FIRE AT THE CONNECTOR END. THE ISSUE OCCURRED DURING A THERAPEUTIC AN UNSPECIFIED PROCEDURE . THE FIBER WAS REPLACED AND THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE (NEW FIBER). THERE WERE NO ERRORS REPORTED. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT. THIS EVENT INCLUDES TWO REPORTS: REPORT WITH PATIENT IDENTIFIER (B)(6) (LASER FIBER TFL-FBX150BS LOT KR111723). REPORT WITH PATIENT IDENTIFIER (B)(6) (LASER SYSTEM TFL-PLS SN: (B)(6)). THIS REPORT BEING SUBMITTED IS FOR REPORT WITH PATIENT IDENTIFIER (B)(6) (LASER FIBER TFL-FBX150BS LOT KR111723)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854941 150 MICRON TFL BALL TIP SINGLE USE FIBER POWERED LASER SURGICAL INSTRUMENT GEX GYRUS ACMI, INC. TFL-FBX150BS KR111723

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown LASER UNIT TFL-PLS SN: (B)(6).