BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON

    MDR report key: 1038338 · Received May 6, 2008

    Report

    Report Number
    1038338
    Event Type
    Malfunction
    Date Received
    May 6, 2008
    Date of Event
    February 22, 2008
    Report Date
    March 3, 2008
    Manufacturer
    ETHICON ENDO SURGERY
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER SURGEON - 3 DIFFERENT CUTTERS TESTED AND EACH DID NOT WORK PROPERLY PER DR. REF ATW45. LOT # D4JX78 EXP. 11/2012. LOT #D4JP70 EXP. 10/2012. LOT #D4JP04 EXP. 10/2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDOPATH ARTICULATING CUTTER GCJ ETHICON ENDO SURGERY

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR