BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA ROTICULATOR 60-3.5 SULU

    MDR report key: 2950504 · Received February 5, 2013

    Report

    Report Number
    1219930-2013-00054
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    December 28, 2012
    Report Date
    January 7, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: COLECTOMY. ACCORDING TO THE REPORTER: SURGEON STATED THAT SHE STAPLED DISTAL SIGMOID BOWEL AND THAT STAPLE LINE LEAKED STOOL INTO ABDOMINAL CAVITY. THERE MAY HAVE BEEN BACK PRESSURE, BUT WAS SURPRISED THAT STAPLE LINE LEAKED. THE PATIENT WAS GIVEN A COLOSTOMY. NOT SURE IF SURGEON PLANNED ON ANASTOMOSING BOWEL. NO REINFORCEMENT MATERIAL WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48690 ENDO GIA ROTICULATOR 60-3.5 SULU DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other