BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ILS CURVED CIR STAPL

    MDR report key: 1080025 · Received July 17, 2008

    Report

    Report Number
    3005075853-2008-00564
    Event Type
    Malfunction
    Date Received
    July 17, 2008
    Report Date
    June 25, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO 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 CREATED AN INCOMPLETE ANASTAMOSIS. THE INCOMPLETE ANASTAMOSIS WAS DISCOVERED DURING A LEAK TEST. THE INCOMPLETE PORTION OF THE ANASTAMOSIS WAS SUTURED BY HAND. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE ILS CURVED CIR STAPL GDW ETHICON ENDO-SURGERY, LLC NA E4KD0P

    Patients

    Seq Age Sex Outcome Treatment
    1