BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXUM REUSABLE BIOPSY FORCEPS

    MDR report key: 472682 · Received July 16, 2003

    Report

    Report Number
    1037905-2003-00046
    Event Type
    Malfunction
    Date Received
    July 16, 2003
    Date of Event
    May 16, 2003
    Report Date
    June 16, 2003
    Manufacturer
    WILSON-COOK MEDICAL, INC.
    Product Code
    BWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE, A PHYSICIAN USED A WILSON-COOK MAXUM REUSABLE BIOPSY FORCEPS TO ATTAIN A TRANSBRONCHIAL BIOPSY. THE FORCEPS WERE INSPECTED PRIOR TO ADVANCEMENT THROUGH THE ENDOSCOPE. ONE BIOPSY WAS SUCCESSFUL. WHEN THE DEVICE WAS ADVANCED TO COLLECT THE SECOND BIOPSY, A PORTION OF ONE CUT WAS MISSING. THE PT WAS GIVEN WASHOUTS AND A CHEST X-RAY. HOWEVER, THE MISSING PORTION OF THE CUP WAS UNABLE TO BE LOCATED. AN INJURY TO THE PT WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXUM REUSABLE BIOPSY FORCEPS REUSABLE BIOPSY FORCEPS BWH WILSON-COOK MEDICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention