BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    MDR report key: 7769365 · Received August 9, 2018

    Report

    Report Number
    1820334-2018-02443
    Event Type
    Malfunction
    Date Received
    August 9, 2018
    Date of Event
    July 23, 2018
    Report Date
    September 21, 2018
    Manufacturer
    COOK INC
    Product Code
    GEX
    UDI-DI
    00827002252936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    METHOD CODES: 4114, DEVICE NOT RETURNED. H6 : CONCLUSION CODES: 4135, CAUSE NOT ESTABLISHED. INVESTIGATION EVALUATION: THE COMPLAINT DEVICE WAS NOT RETURNED FOR AN EVALUATION AND NO PHOTOGRAPHS WERE PROVIDED. WITHOUT THE COMPLAINT DEVICE, A DEVICE FAILURE ANALYSIS WAS UNABLE TO BE PERFORMED. A DOCUMENT BASED INVESTIGATION WAS CONDUCTED INCLUDING A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, QUALITY CONTROL DATA, AND TRENDS. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR LOT NUMBER 8653286 AND NOTED THERE ARE NO CONFORMANCE. A REVIEW OF COMPLAINT HISTORY RECORDS REVEALED THIS IS THE ONLY COMPLAINT ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER 8653286. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. 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. PER THE INSTRUCTIONS FOR USE (IFU), PRECAUTION SECTION: NEVER SUBJECT FIBEROPTIC TO SHARP BENDS IN HANDLING, USE, OR STORAGE. DISCARD ANY FIBEROPTIC ASSEMBLY THAT IS CRACKED OR BROKEN OR DOES NOT MEET MINIMUM TRANSMISSION STANDARDS. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS VISUALLY/FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO RELATED GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. WITHOUT THE DEVICE RETURNED FOR INSPECTION AND ANALYSIS, THE CAUSE FOR THE BROKEN FIBER 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

    THERE HAS BEEN NO NEW INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: 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

    IT WAS REPORTED DURING A LASER OF KIDNEY STONES PROCEDURE, THE CUSTOMER OPENED THE LASER FIBER PACKAGE AND THE FIBER WAS BROKEN AND DAMAGED. THEY JUST WIPED THE PRODUCT OVER. IT WAS NOT USED ON A PATIENT. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611296 COOK® SINGLE-USE HOLMIUM LASER FIBER GEX LASER INSTRUMENT, SURGICAL GEX COOK INC 8653286 00827002252936

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR