BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR CUTTER STAPLER

    MDR report key: 3944459 · Received July 18, 2014

    Report

    Report Number
    3005075853-2014-05096
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 30, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K040038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. MULTIPLE REQUEST FOR RETURN OF DEVICE HAVE BEEN MADE BUT NO DEVICE HAS BEEN RETURNED.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: PLEASE EXPLAIN WHAT IS MEANT BY, RECTUM EXTIRPATION? THIS IS NOT CLEAR. RECTUM EXTIRPATION MEANS TO DESTROY TOTALLY OF ANAL CANAL, ANUS AND RECTUM. WAS THE RECTUM REMOVED? IRREVERSIBLY GET ANUS PRAE. HOW DID THE SURGEON COMPLETE THE CASE AFTER THE RECTAL EXTIRPATION?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, AFTER FIRING THE DEVICE IN THE LONGER LINE OF STAPLING NOT THE WHOLE LINE WAS FULLY STAPLED. IN CASE OF ONE OF THE AFFECTED TWO PATIENTS SURGEON NEEDED TO MAKE RECTUM EXTIRPATION INSTEAD OF MAKING ANASTOMOSIS. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED. ONE DEVICE WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421773 CONTOUR CUTTER STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1