BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-REX BIOPSY FORCEPS

    MDR report key: 611667 · Received May 26, 2005

    Report

    Report Number
    6000130-2005-00340
    Event Type
    Malfunction
    Date Received
    May 26, 2005
    Date of Event
    April 25, 2005
    Report Date
    April 27, 2005
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DWZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE FORCEPS BROKE. THE PHYSICIAN WAS ATTEMPTING TO DO A BIOPSY IN THE VENTRICLE OF A HEART TRANSPLANT RECIPIENT TO CHECK TISSUE HEALTH WHEN THE FORCEPS BROKE. THE DEVICE WAS EXCHANGED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER FORCEPS. NO PATIENT INJURIES OR COMPLICATIONS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 T-REX BIOPSY FORCEPS BIOPSY FORCEPS DWZ BOSTON SCIENTIFIC T-REX BIOPSY FORCEPS 50CM 2.2MM PRE-CRV UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN