BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    MDR report key: 5531272 · Received March 29, 2016

    Report

    Report Number
    1820334-2016-00208
    Event Type
    Injury
    Date Received
    March 29, 2016
    Date of Event
    March 7, 2016
    Report Date
    March 7, 2016
    Manufacturer
    COOK INC
    Product Code
    GEX
    UDI-DI
    00827002252950
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: GEX, POWERED LASER SURGICAL INSTRUMENT. (B)(4). THE 510(K): K124030. THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION. A REVIEW OF THE COMPLAINT HISTORY, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, AND QUALITY CONTROL OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE DEVICE IFU DETAILS PRECAUTIONS THAT MAY AFFECT THE LIFE OF THE FIBER AS WELL AS GUIDANCE ON HOW TO PREVENT DAMAGE OF THE FIBER FROM OCCURRING. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF DEVICE HISTORY RECORD SHOWS NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. BASED ON THE AVAILABLE LEVEL OF INFORMATION A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, HOWEVER IT IS POSSIBLE THAT THIS DEVICE BECAME DAMAGED DURING USE, RE-STERILIZATION AT THE USER FACILITY, OR DURING HANDLING OF THE DEVICE. WE WILL CONTINUE TO MONITOR FOR SIMILAR INCIDENTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    DURING A URETEROSCOPY PROCEDURE, THE FIBER BROKE OFF INSIDE THE PATIENT. LASER SETTINGS WERE 12HZ AND 1000MJ. THE SEPARATED PORTION WAS RETRIEVED USING A STONE RETRIEVAL BASKET. NO ADVERSE AFFECTS TO THE PATIENT HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    DURING A URETEROSCOPY PROCEDURE, THE FIBER BROKE OFF INSIDE THE PATIENT. LASER SETTINGS WERE 12HZ AND 1000MJ. THE SEPARATED PORTION WAS RETRIEVED USING A STONE RETRIEVAL BASKET. NO ADVERSE AFFECTS TO THE PATIENT HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187361 COOK® SINGLE-USE HOLMIUM LASER FIBER GEX COOK INC NA 00827002252950

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention