BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    MDR report key: 8013742 · Received October 29, 2018

    Report

    Report Number
    1820334-2018-03275
    Event Type
    Malfunction
    Date Received
    October 29, 2018
    Date of Event
    October 9, 2018
    Report Date
    December 7, 2018
    Manufacturer
    COOK INC
    Product Code
    GEX
    UDI-DI
    00827002252936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION A VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL DATA. THE CUSTOMER RETURNED ONE OPENED PACKAGE LABELED WITH PART NUMBER HLF-S200-HSMA AND LOT NUMBER 8644179. THE FIBER WAS RETURNED WITHOUT THE PROTECTIVE COIL AND PACKAGING TRAY. VISUAL EXAMINATION OF THE RETURNED DEVICE CONFIRMED THE FIBER WAS RETURNED IN TWO PIECES. THE DISTAL SEGMENT MEASURED 197.8CM. FIBER OPTICS IS PROTRUDING 6MM FROM THE BLUE POLYMER CLADDING ON THE DISTAL TIP. THE POINT OF SEPARATION OCCURRED 101.5CM FROM THE DISTAL END OF THE SILICONE PLUG COVER. THE TOTAL LENGTH OF THE RETURNED FIBER MEASURED 299.3CM. UNDER MAGNIFICATION, THE POINT OF SEPARATION ON THE WHITE SLEEVE HAS A MELTED AND CHARRED APPEARANCE. FIBER WAS BROKEN AND VISIBLE AT THE EDGE OF THE SLEEVE. FIBER CLADDING ALSO HAD A MELTED APPEARANCE. NO OTHER DAMAGE OR MANUFACTURING ANOMALIES WERE NOTED ON THE DEVICE. LASER FIBERS ARE TESTED DURING MANUFACTURING PROCESSES USING MANUFACTURING INSTRUCTIONS. TESTING ASSURES THE FIBER IS RECOGNIZED AND NO FAILURE CODES ARE PRESENT. IN ADDITION, ASSURING NO BREAKS ARE PRESENT ALONG THE FIBER LENGTH AND GREEN OUTPUT FROM END OF FIBER CREATES A WELL-DEFINED CIRCLE. THE DEVICE IS INSPECTED VISUALLY AND FUNCTIONALLY FOR CRACKS AND FRACTURES BY MANUFACTURING AND QUALITY CONTROL AND NO NOTABLE GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NOTED THERE WERE NO NON-CONFORMANCES THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. A SEARCH OF COMPLAINT RECORDS REVEALED THIS IS THE ONLY COMPLAINT ASSOCIATED WITH COMPLAINT LOT NUMBER 8644179 FOR THE REPORTED FAILURE MODE. THE INSTRUCTIONS FOR USE (IFU) ADVISES THAT 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. VISUAL EXAMINATION OF THE DEVICE CONFIRMED THE FIBER WAS SEPARATED. THE RETURNED FIBER WAS BROKEN AND HAD A MELTED DISTORTED APPEARANCE. THE EXACT CAUSE OF THE FIBER DAMAGE COULD NOT BE ESTABLISHED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO ADDITIONAL RISK MITIGATING ACTIVITY IS REQUIRED AT THIS TIME. 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

    THERE HAS BEEN NO NEW INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

    Description of Event or Problem · 0

    FURTHER EVENT DETAILS WERE OBTAINED: IT WAS REPORTED, PRIOR TO STARTING A LASER LITHOTRIPSY PROCEDURE, THEY NOTICED DAMAGE TO THE FIBER PACKAGING AND THE FIBER LOOKED DAMAGED. THE FIBER WAS PLUGGED IT IN TO SEE IF IT WORKED AND SOME "SPARKING" WAS OBSERVED AT THE TIP OF THE FIBER WHEN IT WAS TESTED. A NEW FIBER WAS OPENED AND THEY WERE ABLE TO COMPLETE THE CASE.

    Additional Manufacturer Narrative · 1

    PMA/510K # K124030. (B)(4). 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, THE COOK® SINGLE-USE HOLMIUM LASER FIBER WAS OPENED AND IT STARTED SPARKING OFF THE SIDE. NO PATIENT INJURY. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE PATIENT AND THE EVENT. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854442 COOK® SINGLE-USE HOLMIUM LASER FIBER GEX LASER INSTRUMENT, SURGICAL GEX COOK INC 8644179 00827002252936

    Patients

    Seq Age Sex Outcome Treatment
    1 DORNIER LASER| DORNIER LASER