BEUDAMED
    FDA Adverse Event Death Summary report: N

    RADIAL JAW 4 BIOPSY FORCEPS

    MDR report key: 1642347 · Received March 29, 2010

    Report

    Report Number
    3005099803-2010-01458
    Event Type
    Death
    Date Received
    March 29, 2010
    Report Date
    March 4, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THE EVENT IS UNKNOWN. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE MODEL AND LOT NUMBER; THEREFORE, THE CATALOG #, LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B) (4) - NO CODE AVAILABLE (NO PRODUCT FAILURE REPORTED). THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B) (4)

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 SINGLE USE BIOPSY FORCEPS WAS USED DURING A PROCEDURE.ACCORDING TO THE COMPLAINANT, THE PATIENT WHO HAD A VERY FRIABLE TUMOR AND UNDERLYING HEALTH ISSUES BLED AFTER A BIOPSY AND EXPIRED. THE COMPLAINANT REPORTED THAT ¿THEY COULD EASILY HAVE NICKED A VESSEL WHILE TAKING THE BIOPSY¿ AND ¿DIDN'T FEEL THAT THE FORCEPS HAD ANYTHING TO DO WITH IT.¿ ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT (INCLUDING ANY AUTOPSY RESULTS) HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW 4 BIOPSY FORCEPS FORCEPS, BIOPSY, NON-ELECTRIC FCL BOSTON SCIENTIFIC - COSTA RICA UNK356

    Patients

    Seq Age Sex Outcome Treatment
    1 Death