BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    MDR report key: 7041613 · Received November 17, 2017

    Report

    Report Number
    1820334-2017-03924
    Event Type
    Malfunction
    Date Received
    November 17, 2017
    Date of Event
    November 1, 2017
    Report Date
    March 16, 2018
    Manufacturer
    COOK INC
    Product Code
    GEX
    UDI-DI
    00827002252967
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE OPENED COOK SINGLE-USE HOLMIUM LASER FIBER PACKAGE LABELED RPN HLF-S550-HSMA, LABEL LOT NUMBER 8037369 WAS RECEIVED. THERE WAS NO QUARTZ EXTENDING FROM THE DISTAL TIP. UNDER MAGNIFICATION THE BLUE CLADDING HAS A MELTED APPEARANCE. AT 2.3 CM FROM THE DISTAL TIP THE QUARTZ WAS BROKEN AND SEPARATED. INSIDE THE CLADDING HAD A CHARRED APPEARANCE AND WAS SEPARATED. THE QUARTZ WAS NOT VISIBLE FROM THE POINT OF SEPARATION. THE FIBER PLUG WAS SECURE. BASED ON THE EVIDENCE PRESENTED BY THE SAMPLE AND PREVIOUS INFORMATION ALREADY PROVIDED, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED.

    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, THE DEVICE HISTORY RECORD, 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 ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER. A REVIEW OF COMPLAINT HISTORY FOUND NO OTHER COMPLAINTS HAVE BEEN RECEIVED AGAINST THIS COMPLAINT DEVICE LOT NUMBER. BASED ON THE PROVIDED INFORMATION THE DEFINITIVE ROOT CAUSE FOR THE FIBER BREAKAGE COULD NOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS. 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 AREA REPRESENTATIVE REPORTED THAT THE COOK SINGLE-USE HOLMIUM LASER FIBER WAS BRITTLE. WHEN IT WAS INSERTED INTO THE SCOPE THE FIBER BENT BACK AND BROKE. THIS OCCURRED PRIOR TO PATIENT CONTACT. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THIS PRODUCT ISSUE. A NEW FIBER WAS PUT IN THE LASER AND THE PROCEDURE WAS COMPLETED. ADDITIONAL PATIENT AND EVENT DETAILS HAVE BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820971 COOK® SINGLE-USE HOLMIUM LASER FIBER GEX LASER INSTRUMENT, SURGICAL GEX COOK INC 00827002252967

    Patients

    Seq Age Sex Outcome Treatment
    1