BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA ROTICULATOR 60-3. 5 SULU

    MDR report key: 812132 · Received February 1, 2007

    Report

    Report Number
    1219930-2007-00059
    Event Type
    Injury
    Date Received
    February 1, 2007
    Date of Event
    March 10, 2006
    Report Date
    March 14, 2006
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GAG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE. THIS EVENT WAS ORIGINALLY REPORTED AS AN ASR TYPE "MALFUNCTION" DURING APRIL OF 2006. HOWEVER, ADDITIONAL INFORMATION RECEIVED 1/19/2007 CLARIFIES/CONFIRMS DETAILS WHICH RESULTED IN CHANGING THIS REPORT TO AN MDR REPORTABLE "SERIOUS INJURY."

    Description of Event or Problem · 1

    PROCEDURE: LAP ASSISTED DISTAL GASTRECTOMY. IT WAS INITIALLY REPORTED IN 2006 THAT THE STAPLER WAS FIRED INTO A SMALL BOWEL. THE PATIENT SIDE OF THE TISSUE WAS STAPLED PROPERLY. HOWEVER, TISSUE SPECIMEN WAS NOT STAPLED AT ALL. ADDITIONAL INFORMATION RECEIVED ON 1/19/2007 CLARIFIES/CONFIRMS THAT A SMALL INCISION WAS MADE SPECIFICALLY TO REINFORCE THE TISSUE AND POOR STAPLE LINE WITH A SECOND DEVICE. NOTE. THIS EVENT WAS ORIGINALLY REPORTED AS AN ASR TYPE "MALFUNCTION" DURING APRIL OF 2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA ROTICULATOR 60-3. 5 SULU DISPOSABLE SURGICAL STAPLER GAG NORTH HAVEN - USS * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention