BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-REX BIOPSY FORCEPS

    MDR report key: 734375 · Received June 27, 2006

    Report

    Report Number
    6000130-2006-00158
    Event Type
    Malfunction
    Date Received
    June 27, 2006
    Date of Event
    May 31, 2006
    Report Date
    June 1, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DWZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED DIAGNOSTIC PROCEDURE, FORCEPS REMOVAL DIFFICULTY OCCURRED. THE T-REX BIOPSY FORCEPS WIRE BROKE, LEAVING THE JAWS IN AN OPEN POSITION, MAKING IT "IMPOSSIBLE" TO REMOVE THE DEVICE FROM THE PATIENT. WITH THE USE OF A HEMOSTAT, THE PHYSICIAN WAS ABLE TO GRAB THE WIRES, CLOSE THE JAWS, AND REMOVE THE T-REX BIOPSY FORCEPS FROM THE PATIENT. CURRENT PATIENT STATUS IS REPORTED AS "OKAY". THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER T-REX BIOPSY FORCEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 T-REX BIOPSY FORCEPS BIOPSY FORCEPS DWZ BOSTON SCIENTIFIC NA 8444638

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN