BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HURST ESOPHAGEAL BOUGIE 30 FR

    MDR report key: 1586567 · Received January 11, 2010

    Report

    Report Number
    3004365956-2010-00001
    Event Type
    Malfunction
    Date Received
    January 11, 2010
    Date of Event
    December 21, 2009
    Report Date
    December 21, 2009
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KCD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION YET. A F/U INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: DURING A SURGICAL PROCEDURE, WHILE USING THE DEVICE, THE BOUGIE WAS ACCIDENTLY STAPLED CAUSING IT TO SPLIT OPEN WHICH RESULTED IN THE TUNGSTEN SPILLING INTO THE PT'S STOMACH. IT WAS INDICATED THE BOUGIE WAS STAPLED APPROXIMATELY 3/4 OF THE WAY FROM THE END. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HURST ESOPHAGEAL BOUGIE 30 FR ESOPHAGEAL BOUGIE KCD TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1