BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 31MM SINGLE-USE STAPLER

    MDR report key: 2851205 · Received November 26, 2012

    Report

    Report Number
    2647580-2012-00744
    Event Type
    Injury
    Date Received
    November 26, 2012
    Date of Event
    October 26, 2012
    Report Date
    November 5, 2012
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO
    Product Code
    GAG
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LOW ANTERIOR RESECTION WITH END TO END ANASTOMOSIS. ACCORDING TO THE REPORTER: CUSTOMER REPORTED MALFUNCTION OF THE EEA31 IN PERFORMING END TO END ANASTOMOSIS. THERE WERE NO STAPLES IN THE EEA31. THE CUSTOMER ALSO REPORTED THAT BOWEL WAS CUT FROM THE CIRCULAR KNIFE, DONUTS WERE FORMED, BUT THERE WAS NO STAPLE LINE FORMATION BECAUSE STAPLES WERE MISSING IN THE STAPLER. CUSTOMER INSPECTED THE STAPLE LINE AND THE INSTRUMENT AND COULDN'T FIND STAPLES. THE CUSTOMER FINISHED PROCEDURE BY CLOSING OPEN ENDS OF THE BOWEL WITH SUTURES AND THEY USED ANOTHER EEA31 FOR END TO END ANASTOMOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA 31MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GAG COVIDIEN, FORMERLY USSC PUERTO RICO P2D0524X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other