BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR CURVED CUTTER STAPLER

    MDR report key: 1902751 · Received November 18, 2010

    Report

    Report Number
    3005075853-2010-06592
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 28, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K040038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING THE PROCEDURE, COLON RESECTION WAS PERFORMED WITH A COMPETITOR DEVICE AND THE RECTUM RESECTION WITH THE (B)(4) AND ITS INITIAL RELOAD (FIRST USE OF THE DEVICE): THE DEVICE CUT BUT NO STAPLE. ANOTHER SECTION OF THE RECTUM PART WAS PERFORMED LOWER (UNDER THE (B)(4) SECTION) AND THE ANASTOMOSIS WAS PERFORMED MANUALLY (MANUAL SUTURE). LONGER PROCEDURE OF 45 MINUTES. NO FOLLOW-OPERATIVELY; THE PATIENT IS WELL.

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE WOULD NOT STAPLE BUT CUT. NO MORE DETAIL. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THE INTRAOCULAR LENS WAS EXPLANTED WITHOUT COMPLICATION 4 MONTHS AFTER IMPLANT DUE TO THE PATIENT'S UNWANTED HALOS AND GLARE. HALOS AND GLARE ARE A KNOWN AND LABELED POSSIBLE SIDE EFFECT OF ALL MULTIFOCAL LENS IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR CURVED CUTTER STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. G4TV4P

    Patients

    Seq Age Sex Outcome Treatment
    1