BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON ENDO LINER CUTTER

    MDR report key: 1963777 · Received January 12, 2011

    Report

    Report Number
    MW5019015
    Event Type
    Malfunction
    Date Received
    January 12, 2011
    Date of Event
    December 29, 2010
    Report Date
    January 12, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TWO ETHICON 75 MM STAPLERS FAILED DURING USE ON THE COLON. THEY DID NOT FIRE, STAPLE, OR SEAL THE ANASTOMOSIS. BECAUSE OF THIS MORE COLON HAD TO BE REMOVED THAN ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO LINER CUTTER 75 MM LINEAR CUTTER GDW ETHICON ENDO-SURGERY, LLC. NTLC75 G4TH78
    2 ETHICON ENDO LINEAR CUTTER 75 MM LINEAR CUTTER GDW ETHICON ENDO-SURGERY, LLC. NTLC75 G4U47J

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR