BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    MDR report key: 9444253 · Received December 10, 2019

    Report

    Report Number
    1820334-2019-03067
    Event Type
    Malfunction
    Date Received
    December 10, 2019
    Date of Event
    October 10, 2019
    Report Date
    December 10, 2019
    Manufacturer
    COOK INC
    Product Code
    GEX
    UDI-DI
    00827002252943
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). PMA/510K #: K133788. INVESTIGATION ¿ EVALUATION. A VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD, THE INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, AND QUALITY CONTROL DATA. ONE DEVICE WAS RETURNED FOR INVESTIGATION. VISUAL EXAMINATION CONFIRMED THE FIBER WAS RETURNED IN UNUSED CONDITION. THE FIBER WAS SEPARATED FROM THE PLUG ASSEMBLY. THERE WAS 6MM OF THE FIBER EXTENDING FROM THE BLUE SILICONE JACKET. THE FULL LENGTH OF THE FIBER WAS 296.3CM. THE BLUE JACKET AT THE PROXIMAL END OF THE FIBER HAD A MELTED APPEARANCE. WITH VISIBLE CHARRING ON THE JACKET AND OPTIC FIBER. THIS INDICATES THAT ENERGY WAS TRANSMITTED THROUGH THE FIBER. CHARRING WAS VISIBLE ON THE INSIDE EDGE OF THE SILICONE CONNECTOR COVER. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF COMPLAINT HISTORY RECORDS SHOWS NO OTHER COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT. BECAUSE THERE ARE NO RELATED NON-CONFORMANCES, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO OTHER RELATED COMPLAINTS FROM THE LOT HAVE BEEN RECEIVED FROM THE FIELD, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. THE INSTRUCTIONS FOR USE (IFU), PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: IMPROPER HANDLING. NEVER SUBJECT FIBER OPTICS TO SHARP BENDS IN HANDLING, USE, OR STORAGE. FIBER SHOULD NOT BE CLAMPED WITH FORCEPS OR OTHER SECURING INSTRUMENTS AS IT COULD RESULT IN FIBER DAMAGE OR BREAKAGE. CUSTOMER REPORTED THAT THE LASER FIBER WAS FOUND BROKEN WHEN THEY OPEN THE PACKAGE, HOWEVER, DEVICE FAILURE ANALYSIS CONFIRMED VISIBLE CHARRING ON THE JACKET AND FIBER OPTIC INDICATING ENERGY WAS TRANSMITTED THROUGH THE FIBER. THE COMPLAINT WAS CONFIRMED BASED ON CUSTOMER TESTIMONY AND TECHNICAL EVALUATION OF RETURNED DEVICE. FROM AVAILABLE INFORMATION, IMPROPER HANDLING OF LASER FIBER IS MOST PROBABLE CAUSE OF REPORTED ISSUE AND ANY PRECAUTIONS LISTED IN IFU MAY CONTRIBUTE TO THIS ISSUE. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. COOK MEDICAL WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    IT WAS REPORTED, PRIOR TO A URETEROSCOPY AND LASERTRIPSY USING A COOK SINGLE-USE HOLMIUM LASER FIBER, THE FIBER WIRE DETACHED FROM THE RED CONNECTING HUB. THE CASE WAS COMPLETED BY USING A NEW SAME TYPE OF FIBER. IT WAS ALSO INITIALLY REPORTED THAT THEY WERE JUST ABOUT THE USE THE LASER MACHINE BUT WHEN THEY OPENED THE PACK THE DEVICE WAS BROKEN. NO ADVERSE EFFECTS WERE REPORTED DUE TO THE ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241104 COOK® SINGLE-USE HOLMIUM LASER FIBER GEX LASER INSTRUMENT, SURGICAL GEX COOK INC G25294 8682718 00827002252943

    Patients

    Seq Age Sex Outcome Treatment
    1