BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 31MM SINGLE-USE STAPLER

    MDR report key: 2170006 · Received May 18, 2011

    Report

    Report Number
    2647580-2011-00350
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 10, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    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: LOWER ANTERIOR RESECTION/DOUBLE STAPLING. ACCORDING TO THE REPORTER: AFTER ANASTOMOSIS, THE SURGEON WORRIED ABOUT LEAKAGE, SO A COVERING OF THE STOMA WAS BUILT. THE SURGEON DID NOT PERFORM AN INTRA-OPERATIVE LEAK TEST, AND IT IS UNK IF THERE IS ANY EVIDENCE OF IMPROPER STAPLE FORMATION. ACCORDING TO THE REPORTER, THE STAPLER DID NOT PERFORM AS INTENDED. NO BLEEDING WAS REPORTED. NOTHING FELL INTO THE PT CAVITY. NO TISSUE WAS DAMAGED. THE OPERATING ROOM TIME WAS EXTENDED MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA 31MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW USSC PUERTO RICO P1B0438H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other