BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    MDR report key: 7574654 · Received June 6, 2018

    Report

    Report Number
    1820334-2018-01540
    Event Type
    Malfunction
    Date Received
    June 6, 2018
    Date of Event
    May 15, 2018
    Report Date
    September 4, 2018
    Manufacturer
    COOK INC
    Product Code
    GEX
    UDI-DI
    00827002235533
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION CONCLUSION CODE: CAUSE TRACED TO TRANSPORT/STORAGE (4308). INVESTIGATION ¿ EVALUATION: A VISUAL INSPECTION AND DIMENSIONAL VERIFICATION OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED. THIS INCLUDED A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, AND TRENDS. ONE HLF-S273-H30 WAS RECEIVED WITHOUT THE PACKAGE OR LABEL LOT NUMBER. THE FIBER WAS RETURNED IN A TANGLED STATE. THE FIBER WAS BROKEN 55.4CM FROM THE DISTAL TIP; 6MM OF QUARTZ EXTENDED FROM THE DISTAL EDGE OF THE CLADDING. THE PROXIMAL SEGMENT MEASURED 245.4CM IN LENGTH TOTALING APPROXIMATELY 300.8CM OF FIBER RETURNED INDICATING FIBER REMAINS WITHIN SPECIFICATION. UPON RETURN THE FIBER SEGMENTS REMAINED ATTACHED BY A THIN PIECE OF CLADDING. WHILE HANDLING THE DEVICE DURING THE INVESTIGATION COMPLETE SEPARATION OCCURRED. UNDER MAGNIFICATION THE FIBER BENEATH THE CLADDING IS BROKEN AND HAS RAGGED EDGES. NO VISIBLE CHARRING WAS OBSERVED ON OR NEAR POINT OF SEPARATION. THE DEVICE HISTORY LOT RECORD FOR LOT NUMBER 8326382 WAS REVIEWED AND NOTED THERE WERE NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. A SEARCH OF COMPLAINT RECORDS FOUND THIS IS THE ONLY COMPLAINT ASSOCIATED WITH LOT NUMBER 8326382. THE FIBER WAS RETURNED FOR ANALYSIS IN A TANGLED STATE. A BREAK IN THE FIBER WAS CONFIRMED 55.4CM FROM THE DISTAL TIP WHERE THE FIBER SEGMENTS WERE SEPARATED BUT A THIN PIECE OF CLADDING KEPT THE TWO SEGMENTS CONNECTED. BASED ON THE APPEARANCE OF THE DEVICE, IT IS LIKELY THAT MISHANDLING RESULTED IN THE OBSERVED ISSUE. 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

    THERE HAS BEEN NO INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED ON 6JUN2018.

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510K # K124030. 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, DURING A URETEROSCOPY PLUS LASER OF KIDNEY STONE AND EXTRACTION +/- STENT INSERTION, THE SINGLE-USE HOLMIUM LASER FIBER WAS FOUND BROKEN ON REMOVAL FROM PACKAGING PRIOR TO PATIENT CONTACT. A SECOND FIBRE WAS OPENED AND USED SUCCESSFULLY FOR THE CASE. IT WAS MENTIONED THAT THIS HAD HAPPENED A COUPLE OF TIMES RECENTLY WITH THE SAME PRODUCT AND LOT NUMBER WITH NO DAMAGE TO EQUIPMENT OR PATIENT AS A RESULT. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. REQUEST WAS MADE FOR ADDITIONAL INFORMATION ABOUT THE STATEMENT OF THIS HAPPENING A COUPLE OF TIMES WITH THE SAME PRODUCT AND LOT NUMBER, HOWEVER THE CUSTOMER HAS NOT PROVIDED ANY FURTHER INFORMATION AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415032 COOK® SINGLE-USE HOLMIUM LASER FIBER GEX LASER INSTRUMENT, SURGICAL GEX COOK INC 00827002235533

    Patients

    Seq Age Sex Outcome Treatment
    1