BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    MDR report key: 8428439 · Received March 18, 2019

    Report

    Report Number
    1820334-2019-00651
    Event Type
    Malfunction
    Date Received
    March 18, 2019
    Report Date
    May 7, 2019
    Manufacturer
    COOK INC
    Product Code
    GEX
    UDI-DI
    00827002235533
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE CODE: CORRECTED FROM MATERIAL INTEGRITY PROBLEM TO DEGRADATION PROBLEM. INVESTIGATION ¿ EVALUATION A VISUAL INSPECTION AND FUNCTIONAL TESTING 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, REVIEW OF TRENDS, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL DATA. ONE DEVICE WAS RETURNED FOR INVESTIGATION. PEEL OF LABEL INCLUDED WITH THE DEVICE CONFIRMS THE LOT NUMBER. VISUAL EXAMINATION CONFIRMED 5MM OF FIBER OPTIC PROTRUDES FROM THE DISTAL END. THE OVERALL LENGTH OF THE FIBER MEASURED 296CM WHICH IS WITHIN THE SPECIFICATION. CHARRING WAS VISIBLE BENEATH THE CLADDING BEHIND THE FIBER ON THE DISTAL TIP. FUNCTIONAL TESTING NOTES, USING A RED DOT LASER LIGHT, THE FIBER ILLUMINATED AT THE DISTAL TIP. THERE WAS NO BREAKAGE IDENTIFIED ALONG THE LASER FIBER. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT NUMBER SHOWED NO NON-CONFORMANCES. A REVIEW OF COMPLAINT HISTORY REVEALED NO OTHER COMPLAINTS ASSOCIATED WITH THIS LOT NUMBER. THE INSTRUCTIONS FOR USE (IFU ) PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE. PRECAUTIONS: A NUMBER OF DIFFERENT FACTORS AFFECT THE LIFE OF ANY PARTICULAR FIBER, INCLUDING: EXTENDED LASING AT HIGH POWER, CONTINUOUS LASING WITH THE FIBER TIP IN CONTACT WITH TISSUE, IMPROPER HANDLING AND NOT EXCEED RECOMMENDED POWER LIMITS. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO NOTABLE GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. BASED ON THE INVESTIGATION EVALUATION, THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE FUNCTIONALITY AND DEVICE INTEGRITY PRIOR TO SHIPPING THE INVESTIGATION CONCLUSION IS CAUSE TRACED TO USER; UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO THE EVENT. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED AND 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

    INFORMATION PROVIDED BUT NOT SUBMITTED IN INITIAL MDR REPORT INCLUDES: IT WAS INITIALLY REPORTED THAT THE LASER FIBERS WERE BROKEN DURING THE CASE. ADDITIONAL INFORMATION WAS PROVIDED ON 11MAR2019: THERE WAS NO BREAK IN THE FIBER. THERE WAS NO INJURY TO THE STAFF/END USER. THERE WAS NO NEED FOR ANY ADDITIONAL PROCEDURES, TREATMENTS OR MEDICATIONS AS A RESULT OF THIS ISSUE.

    Additional Manufacturer Narrative · 1

    PMA/510K # K163197. (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 IS REPORTED DURING A URETEROSCOPY WITH LASER LITHOTRIPSY USING AN UNSPECIFIED URETEROSCOPE AND A COOK® SINGLE-USE HOLMIUM LASER FIBER, THE FIBER MALFUNCTIONED DURING THE CASE AND THE TIP ERODED MUCH QUICKER THAN NORMAL. A SECOND (ASSOCIATED PR# (B)(4)) AND THIRD FIBER (ASSOCIATED PR# (B)(4)) WERE OPENED TO FINISH THE CASE. IT IS REPORTED THAT THESE FIBERS MALFUNCTIONED AND ERODED AS WELL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE THREE FIBERS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS FROM THIS ALLEGED PRODUCT COMPLAINT. 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
    223580 COOK® SINGLE-USE HOLMIUM LASER FIBER GEX LASER INSTRUMENT, SURGICAL GEX COOK INC G23553 8781461 00827002235533

    Patients

    Seq Age Sex Outcome Treatment
    1 URETEROSCOPE| URETEROSCOPE