BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    MDR report key: 7125481 · Received December 18, 2017

    Report

    Report Number
    1820334-2017-04603
    Event Type
    Malfunction
    Date Received
    December 18, 2017
    Date of Event
    December 7, 2017
    Report Date
    April 13, 2018
    Manufacturer
    COOK INC
    Product Code
    GEX
    UDI-DI
    00827002252936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. ADDITIONAL INFORMATION: OPTICAL FIBER (546). EVALUATION / INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE A PHYSICAL EXAMINATION COULD NOT BE PERFORMED. HOWEVER, A DOCUMENT-BASED INVESTIGATION WAS PERFORMED. A REVIEW OF DEVICE COMPLAINTS, THE DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, QUALITY CONTROL DATA, AND SPECIFICATIONS WAS CONDUCTED. REVIEW OF THE DEVICE HISTORY RECORD FOUND NO OTHER NON-CONFORMANCES ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER. A COMPLAINT HISTORY SEARCH REVEALED THAT THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THE INSTRUCTIONS FOR USE (IFU) ADVISES A NUMBER OF DIFFERENT FACTORS AFFECT THE LIFE OF ANY PARTICULAR FIBER, INCLUDING: EXTENDING LASING AT HIGH POWER. CONTINUOUS LASING WITH THE FIBER TIP IN CONTACT WITH TISSUE. IMPROPER HANDLING POOR LASING BEAM ALIGNMENT OF FOCUS NEVER SUBJECT FIBER OPTICS TO SHARP BENDS IN HANDLING, USE, OR STORAGE. ALWAYS KEEP CONNECTOR-END DRY AND FREE FROM CONTAMINANTS. DISCARD ANY FIBER OPTIC ASSEMBLY THAT IS CRACKED OR BROKEN, OR DOES NOT MEET MINIMUM TRANSMISSION STANDARDS. DO NOT EXCEED RECOMMENDED POWER LIMITS. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS VISUALLY/FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO NOTABLE GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. 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. H3 OTHER TEXT : BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. ADDITIONAL INFORMATION: OPTICAL FIBER (546). EVALUATION / INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE A PHYSICAL EXAMINATION COULD NOT BE PERFORMED. HOWEVER, A DOCUMENT-BASED INVESTIGATION WAS PERFORMED. A REVIEW OF DEVICE COMPLAINTS, THE DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, QUALITY CONTROL DATA, AND SPECIFICATIONS WAS CONDUCTED. REVIEW OF THE DEVICE HISTORY RECORD FOUND NO OTHER NON-CONFORMANCES ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER. A COMPLAINT HISTORY SEARCH REVEALED THAT THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THE INSTRUCTIONS FOR USE (IFU) ADVISES A NUMBER OF DIFFERENT FACTORS AFFECT THE LIFE OF ANY PARTICULAR FIBER, INCLUDING: EXTENDING LASING AT HIGH POWER. CONTINUOUS LASING WITH THE FIBER TIP IN CONTACT WITH TISSUE. IMPROPER HANDLING POOR LASING BEAM ALIGNMENT OF FOCUS NEVER SUBJECT FIBER OPTICS TO SHARP BENDS IN HANDLING, USE, OR STORAGE. ALWAYS KEEP CONNECTOR-END DRY AND FREE FROM CONTAMINANTS. DISCARD ANY FIBER OPTIC ASSEMBLY THAT IS CRACKED OR BROKEN, OR DOES NOT MEET MINIMUM TRANSMISSION STANDARDS. DO NOT EXCEED RECOMMENDED POWER LIMITS. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS VISUALLY/FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO NOTABLE GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. 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

    THE FIBER TIP DIDN¿T BREAK OFF, THE GLASS ON THE TIP OF THE FIBER BROKE. THERE WAS NO INTERVENTION TO REMOVE ANY PORTION BECAUSE NOTHING WAS LEFT INSIDE THE BODY. THEY PLUGGED IN THE SECOND FIBER AND THE SAME THING HAPPENED TO THE SECOND FIBER BUT THEY WERE ABLE TO FINISH THE PROCEDURE WITH THIS BROKEN FIBER.

    Additional Manufacturer Narrative · 1

    (B)(4). K124030. THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED DURING A URETEROSCOPY PROCEDURE, THE FIRST COOK® SINGLE-USE HOLMIUM LASER FIBER USED HAD THE GLASS TIP BREAK OFF. THE USER OBTAINED A NEW FIBER FROM THE SAME PACKAGE AND THE GLASS TIP BROKE ON THIS AS WELL. THE SCOPE WAS IN A STRAIGHT POSITION AND THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE WITH THE SECOND FIBER USED. NO UNINTENDED PORTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. NO ADVERSE EFFECTS OR CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903971 COOK® SINGLE-USE HOLMIUM LASER FIBER GEX LASER INSTRUMENT, SURGICAL GEX COOK INC 00827002252936

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR