BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PILLING INC. HURST BOUGIE DILATOR

    MDR report key: 300093 · Received October 10, 2000

    Report

    Report Number
    MW1020134
    Event Type
    Injury
    Date Received
    October 10, 2000
    Date of Event
    August 16, 2000
    Manufacturer
    PILLING SURGICAL
    Product Code
    FAT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING LONG LIMB GASTRIC BYPASS SURGERY ON A MORBIDLY OBESE PT THE SURGEON OF RECORD ASKED THE ANESTHETIST TO PASS A BOUGIE DILATOR DOWN THE ESOPHAGUS. THE DEVICE WAS A BLUE #32 RUSCH INC HURST BOUGIE DILATOR. INADVERTENTLY, WHILE WATCHING AND DISCUSSING WITH THE SURGEON, THE ANESTHETIST INSERTED THE BOUGIE BACKWARDS (BLUNT END FIRST) INTO THE ESOPHAGUS CAUSING A "TEAR FROM THE GASTRO-ESOPHAGEAL JUNCTION EXTENDING 3 CMS INTO THE POSTERIOR CARDIA." THIS TEAR WAS REPAIRED INTRAOPERATIVELY AND IT APPEARS THE PT SUFFERED NO LONG-TERM SEQUELAE. IN A SYSTEMS REVIEW, IT WAS NOTED THAT BOTH BLUNT AND TAPERED ENDS OF THE BOUGIE WERE QUITE SIMILAR IN DIAMETER AND EITHER END OF THE DEVICE COULD EASILY PASS DOWN THE ESOPHAGUS. IT IS RPTR'S HOPE THAT THE MFR MIGHT DESIGN A DEVICE WITH A HANDLE ON ONE END MAKING IT IMPOSSIBLE TO PASS IT IMPROPERLY OR THAT BOTH ENDS OF THE DEVICE BE TAPERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PILLING INC. HURST BOUGIE DILATOR #32 BOUGIE DILATOR FAT PILLING SURGICAL 507601 *

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention