BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS

    MDR report key: 336004 · Received May 21, 2001

    Report

    Report Number
    9611174-2001-00001
    Event Type
    Injury
    Date Received
    May 21, 2001
    Date of Event
    March 8, 2001
    Report Date
    May 21, 2001
    Manufacturer
    KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD.
    Product Code
    EZM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTED THAT THE FLEXIBLE TIP FROM AN ESOPHAGEAL GUIDE WIRE BECAME DETACHED DURING AN ESOPHAGEAL DILATATION AT THE MEMORIAL MEDICAL CENTER, PORT LAVACA TX, AND THE REMAINING WIRE PERFORATED THE PATIENT'S DUODENUM. THE PT WAS REFERRED TO ANOTHER HOSPITAL FOR SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23985 OLYMPUS 2 METRE ESOPHAGEAL GUIDE WIRE EZM KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. 55391A 138175 (SUSPECTED)

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization ESOPHAGO-GASTRO-DUODENOSCOPE,| ESOPHAGEAL DILATATION EQUIPMENT,| (MAKE AND MODEL UNKNOWN).| (MAKE AND MODEL UNKNOWN),