BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-REX BIOPSY FORCEPS

    MDR report key: 493002 · Received October 30, 2003

    Report

    Report Number
    6000130-2003-00106
    Event Type
    Malfunction
    Date Received
    October 30, 2003
    Date of Event
    July 9, 2002
    Report Date
    November 21, 2002
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DWZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DURING A BIOPSY PROCEDURE, THE FORCEPS DID NOT CLOSE AFTER BEING OPENED IN THE LEFT VENTRICLE. THE DEIVCE WAS REMOVED WITH THE PIGTAIL AS A UNIT. NO PT INJURIES OR COMPLICATINS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 T-REX BIOPSY FORCEPS BIOPSY FORCEPS DWZ BOSTON SCIENTIFIC FLEXIBLE, 1.8MM JAW OD, 107 CM LENGTH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN