BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    MDR report key: 8907934 · Received August 19, 2019

    Report

    Report Number
    1820334-2019-02041
    Event Type
    Malfunction
    Date Received
    August 19, 2019
    Date of Event
    August 6, 2019
    Report Date
    September 16, 2019
    Manufacturer
    COOK INC
    Product Code
    GEX
    UDI-DI
    00827002252936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN 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, DEVICE HISTORY RECORD, MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, THE INSTRUCTIONS FOR USE, AND QUALITY CONTROL DATA. ONE DEVICE WAS RETURNED FOR INVESTIGATION. THE RETURNED PACKAGING CONFIRMS THE REPORTED COMPLAINT DEVICE LOT NUMBER. INSPECTION OF THE RETURNED DEVICE NOTED: THE FIBER WAS RETURNED IN A USED CONDITION. THE PROTECTIVE SHEATH WAS BENT AT THE END OF THE SILICONE HUB COVER. THE PLUG APPEARED SECURE AND THERE IS NO DISCOLORATION. THE SHEATH HAS A MELTED APPEARANCE AND IS PARTIALLY SEPARATED AND STILL SECURED INSIDE THE PLUG. CHARRING WAS VISIBLE INSIDE THE PROTECTIVE SHEATH AND ON THE BLUE JACKET COVERING THE FIBER AT THE POINT OF SEPARATION, INDICATING THAT ENERGY WAS TRANSFERRED TO THE FIBER. THE FIBER BENEATH THE SHEATH IS COMPLETELY SEVERED AND PULLED OUT OF THE SHEATH DURING INVESTIGATION. THE DISTAL TIP OF THE FIBER IS NOT EXTENDING FROM THE BLUE JACKET. THE FIBER IS VISIBLE AT THE EDGE OF THE JACKET. THE LENGTH OF THE FIBER FROM THE DISTAL TIP TO THE POINT OF SEPARATION MEASURES 287.7CM. 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. THE INSTRUCTIONS FOR USE (IFU), PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: PRECAUTIONS SEVERAL DIFFERENT FACTORS AFFECT THE LIFE OF ANY FIBER, INCLUDING: IMPROPER HANDLING. NEVER SUBJECT FIBER OPTICS TO SHARP BENDS IN HANDLING, USE OR STORAGE. DISCARD ANY FIBEROPTIC ASSEMBLY THAT IS CRACKED OR BROKEN OR DOES NOT MEET MINIMUM TRANSMISSION STANDARDS. FIBER SHOULD NOT BE CLAMPED WITH FORCEPS OR OTHER SECURING INSTRUMENTS AS IT COULD RESULT IN FIBER DAMAGE OR BREAKAGE. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS VISUALLY/FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO RELATED GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. THE COMPLAINT WAS CONFIRMED BASED ON CUSTOMER TESTIMONY AND DEVICE FAILURE ANALYSIS. COOK HAS CONCLUDED THAT BASED ON THE EVIDENCE PRESENTED, THE INVESTIGATION CONCLUSION CAN BE RELATED TO IMPROPER HANDLING OF THE FIBER. THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED, AND IT WAS DETERMINED THAT NO ADDITIONAL RISK MITIGATING ACTIVITY IS REQUIRED. WE WILL CONTINUE TO MONITOR 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

    ADDITIONAL INFORMATION WAS RECEIVED (B)(6) 2019:THE PROCEDURE BEING PERFORMED WAS A FLEXIBLE URETEROSCOPY IN THE KIDNEY. THE FIBER WAS BROKEN BEFORE INTRODUCING IT INTO THE FLEXIBLE URETEROSCOPE AND COULD NOT BE DETECTED. A NEW FIBER WAS USED TO COMPLETE THE PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Additional Manufacturer Narrative · 1

    PMA/510K #: K133788. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED, DURING AN UNSPECIFIED PROCEDURE USING A COOK SINGLE-USE HOLMIUM LASER FIBER, THE PHYSICIAN WAS UNABLE TO USE THE FIBER BECAUSE IT WAS BROKEN. IT IS UNKNOWN AT THIS TIME HOW THE PROCEDURE WAS COMPLETED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS RESULT OF THE ALLEGED MALFUNCTION. ADDITIONAL DETAILS HAVE BEEN REQUESTED REGARDING THE PATIENT AND EVENT. AT THIS TIME NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699773 COOK® SINGLE-USE HOLMIUM LASER FIBER GEX LASER INSTRUMENT, SURGICAL GEX COOK INC G25293 9688746 00827002252936

    Patients

    Seq Age Sex Outcome Treatment
    1 LUMENIS VERSA PULSE LASER (20W)