BEUDAMED
    FDA Adverse Event Death Summary report: N

    RADIAL JAW

    MDR report key: 442006 · Received October 18, 2002

    Report

    Report Number
    6000123-2002-00025
    Event Type
    Death
    Date Received
    October 18, 2002
    Date of Event
    September 16, 2002
    Report Date
    September 19, 2002
    Manufacturer
    MICROVASIVE ENDOSCOPY, A DIV OF BOSTON SCIENTIFIC CORP.
    Product Code
    KNW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING A BRONCHOSCOPY PROCEDURE FOR DIAGNOSIS. THE BIOPSY FORCEPS CAUGHT THE TIP OF THE SCOPE AND COULD NOT BE WITHDRAWN. BLEEDING OCCURRED AND THE BRONCHUS COULD NOT BE RE-ENTERED. THE BLOOD COAGULATED IN THE AIRWAY LEADING TO ASPHYXIATION, BRADYCARDIA AND HYPOXEMIA. SUBSEQUENTLY, THE PT EXPIRED. ATTEMPTS TO OBTAIN FURTHER DETAILS REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD FURTHER DETAILS BE OBTAINED, A SUPPLEMENTAL WILL BE FORWARDED AT THAT TIME. THE DEVICE HAS BEEN RETAINED BY THE USER FACILITY. THEREFORE, NO FAILURE ANALYSIS IS AVAILABLE. WITHOUT EVALUATING THIS DEVICE THE CO CANNOT DETERMINE IF THE DEVICE MET SPECIFICATIONS. WITHOUT FURTHER DETAILS, AND WITHOUT A PRODUCT ANALYSIS, THE CO IS UNABLE TO DETERMINE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW BIOPSY FORCEPS KNW MICROVASIVE ENDOSCOPY, A DIV OF BOSTON SCIENTIFIC CORP. NA 4781859

    Patients

    Seq Age Sex Outcome Treatment
    1 ENDOSCOPE