BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    200 MICRON TFL SINGLE USE FIBER

    MDR report key: 16383783 · Received February 15, 2023

    Report

    Report Number
    3003790304-2023-00078
    Event Type
    Malfunction
    Date Received
    February 15, 2023
    Date of Event
    January 19, 2023
    Report Date
    May 31, 2023
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    GEX
    PMA / PMN Number
    K183647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RETURNED TO THE SERVICE CENTER FOR EVALUATION; HOWEVER, THE DEVICE EVALUATION IS STILL PENDING. SUPPLEMENTAL REPORT(S) WILL BE SUBMITTED SHOULD ANY RELEVANT NEW INFORMATION IS AVAILABLE. 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 DEVICE RETURN EVALUATION . VISUAL INSPECTION WAS PERFORMED NOTED THE SUBJECT DEVICE WAS RECEIVED IN A SEALED, POST-MARKET POUCH. DEVICE INITIAL EVALUATION NOTED THE CONNECTOR END OF THE DEVICE WAS NOT RETURNED . THE CONNECTOR CAP WAS RETURNED AND PORTION WHICH RESTS NEAR THE STRAIN RELIEF APPEARS TO HAVE GREY-BLACK FOREIGN MATERIAL ON THE OUTER RING OF THE CAP. THE BROKEN END OF THE FIBER HAS EVIDENCE OF MELTING OR A TWISTING BREAK. THE DISTAL TIP APPEARS UNUSED. THE LENGTH OF FIBER RETURNED DOES NOT HAVE ANY ABNORMALITIES OTHER THAN THE BROKEN/ MELTED END. DEVICE FURTHER INSPECTION AND EVALUATION OF THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) NOTED THAT THE FIBER APPEARED TO HAVE BEEN MISHANDLED BY THE USER. FIBER BROKE AND BURNT AT STRAIN RELIEF AND STRAIN RELIEF MELTED. CONNECTOR NOT PROVIDED WITH FIBER. OEM NOTED THAT AS THE CONNECTOR WAS NOT RETURNED WITH THE FIBER, NO SERIAL NUMBER COULD BE OBTAINED AND THUS THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. 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. 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, IT IS LIKELY THAT THE DEFINITIVE ROOT CAUSE OF THE FIBER CATCHING FIRE UPON CONNECTING CAN BE ATTRIBUTED TO THE CONSOLE OPTICAL POWER OUT OF SPECIFICATION. IT WAS DISCOVERED THAT THE HIGH POWER MODE WOULD FAIL, CAUSING SPARKING FROM THE DISTAL END OF A SERVICE FIBER. THE EVENT WAS CONFIRMED UPON EVALUATING THE LASER CONSOLE. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: "THE SOLTIVE LASER SYSTEM IS DESIGNED FOR MAXIMUM SAFETY AND PERFORMANCE. UNDER NORMAL OPERATING CONDITIONS AND CAREFUL USE, THE MANUFACTURER RECOMMENDS A CHECK-UP OF THE DEVICE BY A QUALIFIED TECHNICIAN, EVERY 12 MONTHS. THE INTENSIVE USE, DUST, OR CONTINUOUS MOVEMENT OF THE LASER IN DIFFERENT PLACES MAY REQUIRE MORE FREQUENT MONITORING." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    COMPANY REPRESENTATIVE (SALES REP.) CALLED IN TO REPORT THAT THE USER REPORTED A THERMAL EVENT. THERE WAS SPARKS GENERATED WHEN THE USER INSERTED THE FIBER TO THE SOLTIVE GENERATOR. THE REPORTED ISSUE OCCURRED DURING A DIAGNOSTIC (UNSPECIFIED PROCEDURE). IN A FOLLOW UP COMMUNICATION WITH THE CUSTOMER, IT WAS STATED THE ISSUE OCCURRED WHEN THE DOCTOR PLUGGED THE FIBER IN AND THE FIBER SPARKED AND HAD A FLAME AT THE CONSOLE. CUSTOMER STATED, THIS WAS DURING A PROCEDURE BUT DID NOT TOUCH THE PATIENT. NO FURTHER DETAILS WERE PROVIDED. NO HARM WAS REPORTED. NO PATIENT HARM, NO USER INJURY REPORTED. THIS EVENT INCLUDES TWO REPORTS: REPORT WITH PATIENT IDENTIFIER (B)(6) (TFL-PLS SN: (B)(4) LASER SYSTEM SOLTIVE GENERATOR). REPORT WITH PATIENT IDENTIFIER (B)(6) (TFL-FBX200S LOT KR233094 LASER FIBER). THIS REPORT BEING SUBMITTED IS FOR REPORT WITH PATIENT IDENTIFIER (B)(6) (TFL-FBX200S LOT KR233094 LASER FIBER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680259 200 MICRON TFL SINGLE USE FIBER SINGLE USE FIBER GEX GYRUS ACMI, INC. TFL-FBX200S KR233094

    Patients

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