BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPS PLICATOR INSTRUMENT

    MDR report key: 851771 · Received May 16, 2007

    Report

    Report Number
    1226693-2007-00003
    Event Type
    Injury
    Date Received
    May 16, 2007
    Date of Event
    February 26, 2007
    Report Date
    April 24, 2007
    Manufacturer
    NDO SURGICAL, INC.
    Product Code
    KOG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TREATING PHYSICIAN EXPRESSED AN OPINION THAT THE ESOPHAGEAL DILATION PROCEDURE WAS A MEDICAL INTERVENTION REQUIRED TO PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION. THERE WAS NO DEVICE MALFUNCTION. PLEASE SEE SCANNED PAGES.

    Description of Event or Problem · 1

    IN 2007, PT VCV CALLED NDO TO ASK QUESTIONS ABOUT APPLICATOR TREATMENT SIDE EFFECTS. SHE IS EXPERIENCING INTERMITTENT DIFFICULTY SWALLOWING. PT RECEIVED APPLICATOR TREATMENT IN 2006, AND RECEIVED "A SINGLE FULL-THICKNESS PLACATION PLACED ANTERIORLY WITHOUT PROBLEMS.". AT THE TIME OF TREATMENT, NO ESOPHAGEAL ANOMALIES WERE NOTED. SUBSEQUENTLY, TEN MONTHS LATER, THE PT UNDERWENT AN UPPER GI EXAM WITH BARIUM SWALLOWS AND BREAD SWALLOWS. THIS EXAM REVEALED THAT THE PT MANIFESTED A "BORDERLINE STENOTIC STRICTURE OF THE DISTAL ESOPHAGUS." FOUR DAYS LATER, PHYSICIAN PERFORMED AN UPPER GI ENDOSCOPY AND USED A 10-11-12MM ESOPHAGEAL BALLOON TO "SUCCESSFULLY DILATE AN INTRINSIC MILD STENOSIS MEASURING 1 CM IN LENGTH" THAT WAS LOCATED 37 CM FROM THE PT'S INCISSORS. PT REPORTS THAT HER "GERD IS MUCH IMPROVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPS PLICATOR INSTRUMENT ENDOSCOPE/ACCESSORY KOG NDO SURGICAL, INC. 160-01130 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR SEE ATTACHMENT A