BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR CURVED CUTTER STAPLER

    MDR report key: 1904646 · Received November 22, 2010

    Report

    Report Number
    3005075853-2010-06597
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 21, 2010
    Report Date
    November 8, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K040038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2010: ON WHAT FIRING DID THE EVENT OCCUR? 1ST FIRING. IF RELOADED, WERE THERE ANY DIFFICULTIES RELOADING THE DEVICE? NO RELOADING. WAS THE TISSUE TOO THICK? NO. WHAT WAS THE QUALITY OF THE TISSUE IN THE AREA WHERE THE DEVICE WAS FIRED? NOTHING UNTOWARD. YOU HAVE INFORMED US THAT A SHIFT IN INTENSIVE CARE UNIT WAS ALREADY PLANNED BEFORE THE SURGERY, THEN: WHAT WAS THE REASON FOR THE COLOSTOMY? FAILURE OF THE CONTOUR. HAS THIS BEEN REVERSED YET? NO AND WILL NOT BE. PLEASE PROVIDE AN UPDATE CONCERNING THE PATIENT'S HEALTH CONDITION? PATIENT IS FINE. THE ANALYSIS RESULTS SHOWED THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITIONS AND WITH A CARTRIDGE RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED VOID OF STAPLES, WITH THE WASHER COMPLETELY CUT, WITH THE DRIVERS EXPOSED AND WITH THE KNIFE RECESS BELOW THE CARTRIDGE DECK. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH AN ENGINEERING SAMPLE RELOAD AND THE DEVICE FIRED, FORMING ALL STAPLES AND CUTTING AS INTENDED. THE CUT LINE WAS COMPLETE, THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE DEVICE LOCKOUT AND THE RELOAD LOCKOUT WERE FUNCTIONAL. IT SHOULD BE NOTED THAT ALL DEVICES ARE INSPECTED 100% FOR STAPLE PRESENCE BY AN (B)(4), AND ARE VISUALLY INSPECTED 100% AS A FINAL CHECK. IN ADDITION, AT FINISHED GOODS THE DEVICES ARE VISUALLY INSPECTED BASED ON A SAMPLE. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE AFFILIATE. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ULTRA LOW HARTMAN'S PROCEDURE, THERE WAS A TUMOR 4CM FROM THE ANAL VERGE. CONTOUR POSITIONED 15 SECONDS COMPRESSION AND WHEN FIRED, THE CONTOUR CUT BUT ONLY HALF THE STAPLES SEEMED TO HAVE BEEN PRESENT AS THE PATIENT WAS LEFT WITH AN OPEN POSTERIOR WALL. WHEN THE DEVICE WAS EXAMINED, IT WOULD APPEAR ALL OF THE DRIVERS WERE EMPTIED AS THOUGH IT SHOULD HAVE FIRED CORRECTLY. UNFORTUNATELY IT WAS TOO LOW TO SUTURE AND THE PATIENT ENDED UP WITH A COLOSTOMY BAG. SURGERY WAS PROLONGED 20 MINUTES. PATIENT IS STABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR CURVED CUTTER STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. G4R89W

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R CARTRIDGE