BEUDAMED
    FDA Adverse Event Death Summary report: N

    SAVARY GILLIARD DILATOR

    MDR report key: 438338 · Received January 20, 2003

    Report

    Report Number
    1037905-2003-00002
    Event Type
    Death
    Date Received
    January 20, 2003
    Date of Event
    December 10, 2002
    Report Date
    December 23, 2002
    Manufacturer
    WILSON-COOK MEDICAL, INC.
    Product Code
    KNQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE PHYSICIAN USED A WILSON-COOK 48 FRENCH SAVARY GILLIARD DILATOR TO DILATE A STRICTURE IN THE PATIENT'S ESOPHAGUS. A PREPOSITIONED SAVARY WIRE GUIDE WAS NOT IN PLACE AT THE TIME OF THE DILATION. THE DILATOR WAS ADVANCED WITH THE STYLET IN PLACE, WHICH CAUSED A PERFORATION OF THE ESOPHAGUS. THE PATIENT DEVELOPED SUBCUTANEOUS EMPHYSEMA REQUIRING INTUBATION AND SURGICAL REMOVAL OF THE STYLET AND REPAIR OF THE ESOPHAGUS. TWO DAYS AFTER SURGERY, THE PATIENT DEVELOPED SUDDEN HYPOTENSIVE EPISODE AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAVARY GILLIARD DILATOR SAVARY DILATION SETS KNQ WILSON-COOK MEDICAL, INC. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death