BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 28MM SINGLE-USE STAPLER

    MDR report key: 6145576 · Received December 5, 2016

    Report

    Report Number
    2647580-2016-01039
    Event Type
    Injury
    Date Received
    December 5, 2016
    Date of Event
    November 3, 2016
    Report Date
    November 6, 2016
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    GAG
    PMA / PMN Number
    K111825
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI# (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE EEA 28MM SINGLE-USE STAPLER. THE VISUAL INSPECTION AND FUNCTIONAL EVALUATION OF THE DEVICE HAD ACCEPTABLE RESULTS. VISUAL AND FUNCTIONAL TESTING OF THE RETURNED PRODUCT CONFIRMED THE PRODUCT MET SPECIFICATIONS THAT WERE TESTED REGARDING THE REPORTED CONDITION. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY AMENDED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). PHONE NUMBER: (B)(6) USER FACILITY IS PROVIDED. (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING AN ANTERIOR RESECTION PROCEDURE, ONLY HALF OF THE STAPLER FIRED. THE STAPLER CUT THE TISSUE BUT DID NOT APPLY HALF OF THE STAPLES. THE DEVICE PARTIALLY FIRED AND THE STAPLE LINE WAS INCOMPLETE, WHICH WAS CORRECTED BY OVERSEWING. THIS WAS DONE TO PREVENT PERMANENT DAMAGE TO A BODY STRUCTURE. AN ETHIBOND SUTURE WAS USED AS REINFORCEMENT MATERIAL. THERE WAS BLOOD LOSS OF OVER 500CC. SURGICAL TIME WAS EXTENDED OVER 30 MINUTES DUE TO THE PRODUCT PROBLEM, BUT NO ADVERSE EVENT WAS REPORTED AS A RESULT OF THE EXTENSION OF SURGICAL TIME. THE LAST KNOWN PATIENT STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795354 EEA 28MM SINGLE-USE STAPLER STAPLER, SURGICAL GAG COVIDIEN, FORMERLY USSC PUERTO RICO INC EEA28 P6B0609KX

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other| R