BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    MDR report key: 7762561 · Received August 8, 2018

    Report

    Report Number
    1820334-2018-02351
    Event Type
    Malfunction
    Date Received
    August 8, 2018
    Date of Event
    July 9, 2018
    Report Date
    October 30, 2018
    Manufacturer
    COOK INC
    Product Code
    GEX
    UDI-DI
    00827002252943
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION A VISUAL INSPECTION AND DIMENSIONAL VERIFICATION OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, DRAWINGS, INSTRUCTIONS FOR USE, AND QUALITY CONTROL DATA. ONE OPENED PACKAGE LABELED RPN HLF-S273-HSMA WITH LOT NUMBER 8579156 WAS RECEIVED. THE FIBER WAS RETURNED INSIDE THE PROTECTIVE COIL AND SECURED INSIDE THE PACKAGING TRAY. A VISUAL EXAMINATION WAS PERFORMED ON THE DEVICE. THE OVERALL FIBER LENGTH MEASURED APPROXIMATELY 300.1CM. THE LENGTH OF THE OPTIC FIBER EXTENDING FROM THE DISTAL END OF THE BLUE HARD POLYMER CLADDING MEASURED 6.5MM. UNDER MAGNIFICATION SCRATCHES WERE VISUALIZED ON THE EXPOSED OPTIC FIBER IN A CIRCUMFERENTIAL DIRECTION WHICH CAUSES THE AIMING BEAM TO NOT BE ROUNDED AND LIGHT ESCAPES FROM THE SIDE OF THE LASER FIBER. THE LIGHT COULD NOT BE TRANSMITTED TO THE END OF THE FIBER. THIS DEVICE IS TESTED TO ASSURE THE PROGRAM HAS RECOGNIZED THE FIBER AND NO FAILURE CODES ARE PRESENT. IN ADDITION, IT IS INSPECTED TO ASSURE NO BREAKS ARE PRESENT ALONG THE FIBER LENGTH AND THE GREEN OUTPUT FROM THE 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 8579156. 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. THE COMPLAINT IS CONFIRMED BASED ON THE DEVICE ANALYSIS. FROM THE PROVIDED INFORMATION, AN INVESTIGATION CONCLUSION 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

    ADDITIONAL INFORMATION RECEIVED ON 21OCT2018. THERE WAS NO HARM TO THE PATIENT AS THE DEVICE WAS NOT USED. THE REPORTER ALSO ADVISED SHE WAS COMPLETELY SATISFIED WITH THE OUTCOME OF THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(6). 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

    THE DOCTOR REPORTED, PRIOR TO THE COOK® SINGLE-USE HOLMIUM LASER FIBER COMING IN CONTACT WITH THE PATIENT, THAT A HALF A CENTIMETER (CM) BACK FROM THE FIBER TIP, THE GREEN AIMING BEAM LIGHT WAS SHINING OUTWARDS FROM THE FIBER. UPON INSPECTION THEY DISCOVERED, THE AIMING BEAM WAS NOT ROUND. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION. REQUEST WERE MADE FOR ADDITIONAL INFORMATION REGARDING, INTENDED PATIENT DEMOGRAPHICS, INTENDED PATIENT RELEVANT HEALTH HISTORY, INCLUDING PRE-EXISTING CONDITIONS, PROCEDURE BEING CONDUCTED, DESCRIPTION THE PROCEDURE IN DETAIL, ALL DEVICES AND/OR MEDICATIONS UTILIZED IN THE PROCEDURE, IF THE PROCEDURE WAS COMPLETED, AND IF IT WAS, HOW, AND PATIENT OUTCOME; HOWEVER, THE CUSTOMER HAS NOT PROVIDED ANY FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604692 COOK® SINGLE-USE HOLMIUM LASER FIBER GEX LASER INSTRUMENT, SURGICAL GEX COOK INC 8579156 00827002252943

    Patients

    Seq Age Sex Outcome Treatment
    1 ASKU