BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 31MM SINGLE-USE STAPLER

    MDR report key: 2140305 · Received June 15, 2011

    Report

    Report Number
    2647580-2011-00399
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    April 27, 2011
    Report Date
    June 7, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPY. ACCORDING TO THE REPORTER: THE SURGEON WAS UNABLE TO REMOVE THE ANVIL TO ALIGN BEFORE FIRING. HE TRIED TO OPEN THE STAPLER WITH AN APPREHENSION TWEEZERS PRESSURED FIRMNESS. IT WAS REQUIRED TO CONVERT ONLY THIS PART OF THE SURGERY TO AN OPEN PROCEDURE AND SUTURE MANUALLY. NO INJURY. NO PATIENT DAMAGE OCCURRED. NO BLOOD LOSS IN EXCESS OF 250CC WAS REPORTED. OPERATIVE TIME WAS EXTENDED APPROXIMATELY 20 MINUTES. NO UNANTICIPATED TISSUE LOSS OCCURRED.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other