BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEX LASER INSTRUMENT, SURGICAL

    MDR report key: 7741221 · Received August 1, 2018

    Report

    Report Number
    1820334-2018-02390
    Event Type
    Malfunction
    Date Received
    August 1, 2018
    Date of Event
    March 17, 2015
    Report Date
    August 1, 2018
    Manufacturer
    COOK INC
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING FILED AFTER THE ASSOCIATED COMPLAINT WAS REVIEWED UNDER REMEDIATION PROTOCOL (B)(4), COMPLAINT/MDR RETROSPECTIVE REVIEW AND REMEDIATION AND REASSESSED AS REPORTABLE. ADDITIONAL COMPLAINT INVESTIGATION AND RECORD REMEDIATION WAS NOT PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MULTI-USE HOLMIUM LASER FIBER DID NOT WORK WHEN CONNECTED TO THE LASER AFTER BEING STERILIZED. IT WAS FURTHER REPORTED THAT THE TIP OF THE FIBER HAD BEEN CLEAVED, THE CLADDING WAS DAMAGED 2-3 CM FROM THE TIP, THE FIBER WAS BROKEN JUST UNDER THE CLEAVED PORTION, AND PART OF IT HAD FALLEN OUT OF THE CLADDING. THIS FIBER WAS NOT USED ANY FURTHER, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580086 GEX LASER INSTRUMENT, SURGICAL GEX COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1