BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 28MM SINGLE-USE STAPLER

    MDR report key: 2133662 · Received June 8, 2011

    Report

    Report Number
    2647580-2011-00383
    Event Type
    Injury
    Date Received
    June 8, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 24, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: SIGMOIDECTOMY. ACCORDING TO THE REPORTER: AFTER FIRING, SALINE WAS INFUSED FROM ANUS. LEAKAGE WAS FOUND FROM POSTERIOR WALL OF ANASTOMOSIS PART. ADDITIONAL RESECTION AND RE-ANASTOMOSIS WERE DONE. ANOTHER DEVICE WAS USED. NOTHING FELL INTO THE PT CAVITY. TISSUE WAS DAMAGED. OPERATING TIME WAS EXTENDED MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA 28MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW USSC PUERTO RICO P1A0608H

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability