BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON ENDO

    MDR report key: 352260 · Received September 11, 2001

    Report

    Report Number
    MW1022881
    Event Type
    Malfunction
    Date Received
    September 11, 2001
    Date of Event
    September 7, 2001
    Report Date
    September 7, 2001
    Manufacturer
    ETHICON J & J CO
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    STAPLE/CLIP DID NOT CLOSE COMPLETELY. PT DEVELOPED "FREE AIR" POST-OP AND HAD A RETURN TO SURGERY. IT WAS THEN NOTED THAT THE STAPLES DID NOT ADEQUATELY CLOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41424 ETHICON ENDO ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER GDO ETHICON J & J CO ECRA M/L P4KY7X

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR