BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ILS CURVED CIR STAPL

    MDR report key: 2143188 · Received June 28, 2011

    Report

    Report Number
    3005075853-2011-02618
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 30, 2011
    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
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A OPEN PROCEDURE FOR A CLOSING COLOSTOMY PROCEDURE, THE DEVICE DID NOT VISUALIZED THE ORANGE LINE BEFORE FIRING ,THEN THE ANVIL AFTER THE FIRING WAS REMAINED IN THE PATIENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE - THEY HAD TO REMOVE THE ANASTOMOSIS AND USED THE NEW CIRCULAR PRODUCT. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ONE DEVICE WILL BE DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A OPEN PROCEDURE FOR A CLOSING COLOSTOMY PROCEDURE, THE DEVICE DID NOT VISUALIZED THE ORANGE LINE BEFORE FIRING ,THEN THE ANVIL AFTER THE FIRING WAS REMAINED IN THE PATIENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE - THEY HAD TO REMOVE THE ANASTOMOSIS AND USED THE NEW CIRCULAR PRODUCT. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ONE DEVICE WILL BE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE ILS CURVED CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK E4ME7G

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR