BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    MDR report key: 5911847 · Received August 29, 2016

    Report

    Report Number
    1820334-2016-00876
    Event Type
    Injury
    Date Received
    August 29, 2016
    Date of Event
    August 5, 2016
    Report Date
    August 5, 2016
    Manufacturer
    COOK INC
    Product Code
    GEX
    UDI-DI
    00827002235533
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PMA/510(K) # K124030. THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. INVESTIGATION - EVALUATION. A REVIEW OF THE COMPLAINT HISTORY, DIMENSIONAL VERIFICATION, DEVICE HISTORY RECORD, SPECIFICATIONS, AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. RETURNED DEVICE SHOWED NO OBVIOUS EVIDENCE OF THE TIP BEING BROKEN OR SEPARATED HOWEVER, WE CANNOT DEFINITIVELY CONFIRM SEPARATION DID OR DID NOT OCCUR. MATERIAL RETURNED THOUGHT TO BE THE SEPARATED FIBER TIP IS POSSIBLY THE SHRINK TUBE FROM THE NGAGE STONE EXTRACTOR USED DURING THE PROCEDURE. COMPLAINT HAS BEEN CONFIRMED BASED SOLELY ON THE CUSTOMER'S STATEMENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    DURING A URETEROSCOPY AND LASER PROCEDURE, THEY DISCOVERED THE TIP OF THE FIBER BROKE OFF INSIDE THE PATIENT. AN NGAGE EXTRACTOR WAS USED TO RETRIEVE THE FIBRE TIP AND A NEW FIBRE WAS OPENED TO ALLOW THE PROCEDURE TO CONTINUE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THAT THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE AS THE REMOVAL OF THE DEVICE TIP WAS CONDUCTED DURING THE SAME PROCEDURE. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562980 COOK® SINGLE-USE HOLMIUM LASER FIBER GEX LASER INSTRUMENT, SURGICAL GEX COOK INC N/A 00827002235533

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention