BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA ROTICULATOR 60-3.5 SULU

    MDR report key: 1022021 · Received March 31, 2008

    Report

    Report Number
    1219930-2008-00249
    Event Type
    Injury
    Date Received
    March 31, 2008
    Date of Event
    March 6, 2008
    Report Date
    March 27, 2008
    Manufacturer
    NORTH HAVE - USS
    Product Code
    GAG
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    PROCEDURE: LAP GASTRIC BYPASS. ACCORDING TO THE REPORTER: STAPLES FAILED TO DEPLOY LEAVING AN OPEN WOUND. AN UNINTENDED GASTRIC RESECTION RESULTED WHERE THE STOMACH WAS OPEN. FURTHER DISSECTION AND APPLICATION OF ANOTHER STAPLE WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA ROTICULATOR 60-3.5 SULU SURGICAL STAPLING DEVICE GAG NORTH HAVE - USS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention