BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    MDR report key: 7112047 · Received December 13, 2017

    Report

    Report Number
    1820334-2017-04194
    Event Type
    Injury
    Date Received
    December 13, 2017
    Report Date
    December 19, 2017
    Manufacturer
    COOK INC
    Product Code
    GEX
    UDI-DI
    00827002252943
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION ¿ EVALUATION: THE COOK® SINGLE-USE HOLMIUM LASER FIBER WAS NOT RETURNED. PHOTOGRAPHS WERE NOT PROVIDED. WITHOUT THE ACTUAL DEVICE, A PHYSICAL EXAMINATION COULD NOT BE PERFORMED. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL DATA, AND SPECIFICATIONS WAS CONDUCTED. BASED ON THE INVESTIGATION EVALUATION, THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE FUNCTIONALITY AND DEVICE INTEGRITY PRIOR TO SHIPPING. REVIEW OF PRODUCTION AND QUALITY DOCUMENTATION DID NOT OBSERVE ANY SPECIFIC ISSUES WITH CURRENT MANUFACTURING OR QUALITY CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF COMPLAINT HISTORY FOUND THERE HAVE BEEN NO OTHER COMPLAINTS RECEIVED ASSOCIATED WITH COMPLAINT DEVICE LOT 8001196. BASED ON THE PROVIDED INFORMATION, NO PRODUCT RETURNED, AND THE RESULTS OF OUR INVESTIGATION, THE DEFINITIVE ROOT CAUSE FOR THE FIBER BREAKAGE COULD NOT BE DETERMINED. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K): 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 THE COOK® SINGLE-USE HOLMIUM LASER FIBER TIP BROKE OFF. THE BROKEN PIECE WAS RETRIEVED SHORTLY AFTER. 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
    894243 COOK® SINGLE-USE HOLMIUM LASER FIBER GEX LASER INSTRUMENT, SURGICAL GEX COOK INC 00827002252943

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention