BEUDAMED
    FDA Adverse Event Death Summary report: N

    OLYMPUS-KEYMED

    MDR report key: 126915 · Received October 17, 1997

    Report

    Report Number
    9611174-1997-00002
    Event Type
    Death
    Date Received
    October 17, 1997
    Date of Event
    August 1, 1997
    Report Date
    October 9, 1997
    Manufacturer
    KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LTD.
    Product Code
    EZM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    A VERBAL REPORT WAS RECEIVED FROM THE MEDICAL PHYSICS ENGINEER ON 1997, INDICATING THAT THE SMALL DILATOR (20-27FR) FROM A KEYMED MANUFACTURED KAD-1 KIT HAD SPLIT DURING USE. HE ASKED IF THE OTHER TWO DILATORS FROM THE KIT COULD BE RETURNED FOR EXAMINATION. NO INDICATION OF ANY INJURY TO A PATIENT WAS GIVEN. THE OTHER TWO DILATORS WERE EXAMINED AND TESTED BY KEYMED AND RETURNED TO THE HOSPITAL AS THEY WERE DEEMED TO BE FIT FOR FURTHER USE. ON 9-1-1997, KEYMED RECEIVED A LETTER FROM THE UK MEDICAL DEVICES AGENCY (MDA), WITH A COPY OF AN INCIDENT REPORT FROM THE HOSPITAL, STATING THAT THE PATIENT SUFFERED A PERFORATED ESOPHAGUS AS A RESULT OF THE INCIDENT. ON 10-3-1997, KEYMED RECEIVED A FURTHER COMMUNICATION FROM THE MDA, TO REPORT THAT THE PATIENT HAD SINCE DIED. KEYMED HAS ASKED THE MDA TO ASSIST IN MAKING THE SUJECT DILATOR AVAILABLE FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS-KEYMED ESOPHAGEAL DILATOR EZM KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LTD. KAD-1 SMALL DILATOR (20-27FR) *

    Patients

    Seq Age Sex Outcome Treatment
    1 Death