BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE ILS CURVED CIR STAPL

    MDR report key: 1221932 · Received November 5, 2008

    Report

    Report Number
    3005075853-2008-02837
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 15, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 11/05/2008. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, THE DEVICE WAS FIRED, BUT THEY DID NOT HEAR THE CRUNCH. UPON REMOVAL OF THE DEVICE, THE ANVIL REMAINED IN THE PATIENT. THE ANVIL WAS RETRIEVED. ANOTHER DEVICE WAS OPENED TO CONTINUE THE PROCEDURE. THE PATIENT RECEIVED A COLOSTOMY, BUT IT IS UNKNOWN WHY AND IT IS ALSO UNKNOWN IF IT IS PERMANENT OR TEMPORARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE ILS CURVED CIR STAPL GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention