BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 1719479 · Received June 7, 2010

    Report

    Report Number
    MW5016271
    Event Type
    Malfunction
    Date Received
    June 7, 2010
    Date of Event
    May 7, 2010
    Report Date
    June 7, 2010
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING COLONOSCOPY/ENDOSCOPY, RADIAL JAW FORCEPS IN CLOSED POSITION WERE NOTED TO BE 1 MM OPEN. NO INJURY TO PATIENT. SCOPES SUBSEQUENTLY FOUND TO HAVE DAMAGE TO CHANNEL. DATES OF USE: (B) (6) 2010 -- (B) (6) 2010. DIAGNOSIS OR REASON FOR USE: BIOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC RADIAL JAW 3 FORCEPS KNW BOSTON SCIENTIFIC 131221805

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR