BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTILITE SINGLE-USE HOLMIUM LASER FIBER

    MDR report key: 9707005 · Received February 13, 2020

    Report

    Report Number
    1820334-2020-00344
    Event Type
    Malfunction
    Date Received
    February 13, 2020
    Report Date
    April 16, 2020
    Manufacturer
    COOK INC
    Product Code
    GEX
    UDI-DI
    00827002486140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT DURING A LASER FLEXIBLE URETERORRENOLITOTRIPSY, A OPTILITE SINGLE-USE HOLMIUM LASER FIBER WAS BEING USED FOR STONE FRAGMENTATION IN THE LOWER CALYX OF THE KIDNEY WHEN THERE WAS A LOSS OF DEFLECTION IN THE FLEXIBLE SCOPE. IT WAS FOUND THAT THE LASER FIBER BROKE INSIDE THE SCOPE, DAMAGING THE DEFLECTION AND INTERNAL COATING. THE PROCEDURE WAS COMPLETED BY USING ANOTHER LASER FIBER. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF REPORTED ISSUE AND NO ADVERSE EFFECTS HAS BEEN REPORTED DUE TO THE ISSUE. INVESTIGATION EVALUATION: REVIEWS OF COMPLAINT HISTORY, DEVICE HISTORY RECORD, SPECIFICATIONS, AND QUALITY CONTROL DATA WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THIS DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF COMPLAINT HISTORY RECORDS FOUND ONE OTHER COMPLAINT ASSOCIATED WITH THE COMPLAINT DEVICE LOT, HOWEVER IT WAS DETERMINED THE FAILURE MODES FOR THE TWO COMPLAINTS WERE NOT RELATED. 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 PROCESSING CONTROLS WERE NOTED. A SEARCH OF OUR DISTRIBUTION CENTER DATABASE FOUND ALL DEVICES FROM THE REPORTED LOT HAVE BEEN SHIPPED. NO SIMILAR PRODUCT FROM THE SAME LOT WAS AVAILABLE FOR INVESTIGATION. THE MOST PROBABLE CAUSE OF THE REPORTED ISSUE IS RELATED TO IMPROPER HANDLING OF THE FIBER AND SHARP BENDING OF THE LASER FIBER MAY HAVE CAUSE THE LASER FIBER BREAKAGE INSIDE THE SCOPE. THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED, AND IT WAS DETERMINED THAT NO ADDITIONAL RISK MITIGATING ACTIVITY IS REQUIRED. WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, 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 RECEIVED ON 02MAR2020: THE PROCEDURE WAS COMPLETED BY USING ANOTHER LASER FIBER.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED 14APR2020: THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT SOLD IN THE UNITED STATES. THERE ARE SIMILAR DEVICES SOLD IN THE UNITED STATES, FOR EXAMPLE CATALOG NUMBER HLF-S273-H30. INFORMATION FOR HLF-S273-H30: COMMON DEVICE NAME:GEX LASER INSTRUMENT, SURGICAL, PRODUCT CODE: GEX, AND PMA/510(K) # K163197. OCCUPATION: OTHER NON-HEALTHCARE PROFESSIONAL: REGULATORY AFFAIRS ASSOCIATE. 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 THAT DURING A LASER FLEXIBLE URETERORRENOLITOTRIPSY, A OPTILITE SINGLE-USE HOLMIUM LASER FIBER WAS BEING USED FOR STONE FRAGMENTATION IN THE LOWER CALYX OF THE KIDNEY WHEN THERE WAS A LOSS OF DEFLECTION IN THE FLEXIBLE SCOPE, WHICH MADE IT "IMPOSSIBLE TO FINISH THE PROCEDURE. IT WAS FOUND THAT THE LASER FIBER BROKE INSIDE THE SCOPE, DAMAGING THE DEFLECTION AND INTERNAL COATING. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. IT WAS REPORTED THAT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION WAS REQUESTED, BUT IT WAS REPORTED THAT NONE WOULD BE RECEIVED AS THIS EVENT WAS REPORTED TO (B)(6) AND NO CONTACT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172892 OPTILITE SINGLE-USE HOLMIUM LASER FIBER GEX COOK INC G48614 9092005 00827002486140

    Patients

    Seq Age Sex Outcome Treatment
    1 ODYSSEY LASER 30 WATT GENERATOR