BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    MDR report key: 7670421 · Received July 9, 2018

    Report

    Report Number
    1820334-2018-02137
    Event Type
    Malfunction
    Date Received
    July 9, 2018
    Date of Event
    June 21, 2018
    Report Date
    August 24, 2018
    Manufacturer
    COOK INC
    Product Code
    GEX
    UDI-DI
    00827002252950
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ( PRODUCT INADVERTENTLY MISSED IN THE INITIAL MEDWATCH REPORT). CONCLUSION CODE: CAUSE NOT ESTABLISHED (4315). INVESTIGATION ¿ EVALUATION. A VISUAL INSPECTION AND DIMENSIONAL VERIFICATION OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED. THIS INCLUDED A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, DRAWINGS, INSTRUCTIONS FOR USE, AND SPECIFICATIONS. ONE OPENED PACKAGE LABELED RPN HLF-S365-HSMA WITH LABEL LOT NUMBER 8566717 WAS RECEIVED. THE DEVICE WAS RETURNED WITHOUT THE PROTECTIVE COIL AND PACKAGING TRAY. IN ADDITION TO THE LASER FIBER, A 5FR YELLOW CATHETER (70CM LONG WITH 50CM INK MARKS) WAS RETURNED. THE ORANGE FLEXIBLE TIP OF THE CATHETER INDICATES THIS IS A 021305 FLEXI-TIP URETERAL CATHETER. THE CATHETER WAS RETURNED WITHOUT IDENTIFYING LOT NUMBER INFORMATION. THE LASER FIBER WAS RETURNED IN ONE SEGMENT MEASURING 298.7CM IN LENGTH. THE DISTAL END OF THE FIBER HAD APPROXIMATELY 1MM OF QUARTZ PROTRUDING FROM THE BLUE CLADDING. UNDER MAGNIFICATION THE CLADDING HAS A BURNT, RAGGED APPEARANCE. A HOLE LOCATED APPROXIMATELY 2-3 MM FROM THE DISTAL END WAS VISUALIZED IN THE CLADDING, QUARTZ WITH A CHARRED APPEARANCE IS EXPOSED FROM THE HOLE. CLADDING HAS A MELTED APPEARANCE. THE TIP OF THE QUARTZ HAS JAGGED EDGES AND A BROKEN APPEARANCE. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES THAT WOULD CONTRIBUTE TO THE REPORTED FAILURE. A COMPLAINT HISTORY SEARCH REVEALED THIS COMPLAINT IS THE ONLY ONE ASSOCIATED WITH LOT NUMBER 8566717. ALL HOLMIUM FIBERS ARE TESTED PER MANUFACTURING SPECIFICATION TO ASSURE THE FIBER IS RECOGNIZED AND FUNCTIONS PROPERLY AND TO ASSURE NO BREAKS ARE PRESENT ALONG THE FIBER LENGTH AND THE GREEN OUTPUT FROM THE END OF FIBER CREATES A WELL-DEFINED CIRCLE. SEVERAL SCENARIOS COULD HAVE CONTRIBUTED TO THE CUSTOMER'S ISSUE WHICH ARE LISTED IN THE INSTRUCTIONS FOR USE (IFU), PRECAUTIONS SECTION. A NUMBER OF DIFFERENT FACTORS AFFECT THE LIFE OF ANY PARTICULAR FIBER, INCLUDING: EXTENDED LASING POWER. CONTINUOUS LASING WITH FIBER TIP IN CONTACT WITH TISSUE. LASING WITH A CONTAMINATED OR DAMAGED PROXIMAL END. IMPROPER HANDLING. POOR LASER BEAM ALIGNMENT OR FOCUS. NEVER SUBJECT FIBER OPTICS TO SHARP BENDS IN HANDLING, USE OR STORAGE. ALWAYS KEEP CONNECTOR END DRY AND FREE FROM CONTAMINATES. DISCARD ANY FIBEROPTIC ASSEMBLY THAT IS CRACKED OR BROKEN, OR DOES NOT MEET MINIMUM TRANSMISSION STANDARDS. DO NOT EXCEED POWER LIMITS. THE LASER FIBER WAS RETURNED AND THE BROKEN TIP OF THE FIBER WAS CONFIRMED. THE RETURNED FIBER HAD A BURNED, RAGGED APPEARANCE. A CONCLUSION AS TO THE CAUSE FOR THE FIBER BREAK COULD NOT BE ESTABLISHED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO NEW EVENT INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED ON (B)(6) 2018.

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510K # - K124030. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED, EARLY IN A BLADDER STONE--CYSTOLITHOTOMY PROCEDURE, THE TIP OF THE COOK® SINGLE-USE HOLMIUM LASER FIBER BROKE OFF. AS REPORTED, ALL PIECES WERE REMOVED FROM PATIENT. AS REPORTED THE DEVICE WAS STRIPPED DOWN AND CONTINUED TO BE USED, PROCEDURE COMPLETED SUCCESSFULLY. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513459 COOK® SINGLE-USE HOLMIUM LASER FIBER GEX LASER INSTRUMENT, SURGICAL GEX COOK INC 8566717 00827002252950

    Patients

    Seq Age Sex Outcome Treatment
    1 COOK OPEN END CATHETER| LUMENIS LASER MACHINE| COOK OPEN END CATHETER