BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WILSON-COOK SIX SHOOTER

    MDR report key: 475715 · Received July 28, 2003

    Report

    Report Number
    475715
    Event Type
    Malfunction
    Date Received
    July 28, 2003
    Date of Event
    May 1, 2003
    Report Date
    May 1, 2003
    Manufacturer
    WILSON-COOK MEDICAL, GEI ENDOSCOPY
    Product Code
    MND
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PT WHO HAD A HISTORY OF PORTAL HYPERTENSION WAS ADMITTED FOR REPEAT UPPER ENDOSCOPY TO REASSESS VARICES. THE OLYMPUS BRONCHOSCOPE WAS INSERTED INTO OROPHARYNX UNDER DIRECT VISUALIZATION. THE PHYSCIAN SAW 2 COLUMNS OF GRADE 3 ESOPHAGEAL VARICES AT THE DISTAL ESOPHAGUS. HE REMOVED THE SCOPE AND ATTACHED THE SIZE #6 SHOOTER WILSON-COOK APPARATUS. HE READVANCED THE SCOPE INTO THE ESOPHAGUS AND READVANCED THE SCOPE DOWN TO THE DISTAL ESOPHAGUS. AT THAT POINT, THE SIZE #6 SHOOTER TIP DISLODGED AND HE HAD TO WITHDRAW THE SCOPE. HE TRIED TO RETRIEVE THE TIP WHICH WAS PLASTIC, SOFT, AND PLIABLE. HE WAS UNABLE TO RETRIEVE IT AND LEFT IT IN THE GASTRIC CAVITY WHERE IT WAS THOUGHT PT WOULD DIGEST IT. HE ATTACHED ANOTHER SIZE #6 SHOOTER TO THE GASTROSCOPE AND REINTUBATED THE ESOPHAGUS AND SUCCESSFULLY BANDED THE 2 COLUMNS OF 3+ VARICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WILSON-COOK SIX SHOOTER ESOPHAGEAL LIGATOR MND WILSON-COOK MEDICAL, GEI ENDOSCOPY MBL-6 1721586

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other