BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR CURVED CUTTER STAPLER

    MDR report key: 1850559 · Received October 1, 2010

    Report

    Report Number
    3005075853-2010-05652
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 9, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K040038
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 10/01/2010. INFORMATION WAS NOT PROVIDED BY THE AFFILIATE. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING RESPONSE WAS RECEIVED ON 9/16/2010. DID THE DEVICE CUT COMPLETELY? YES. THE CONTOUR DEVICE CUT FULLY THE TISSUE.WAS THE STAPLE LINE COMPLETE? NO, STAPLE LINE WAS INCOMPLETE DUE TO RELATED FAILURE.WAS SUTURING USED TO COMPLETE THE CASE? YES. IT WAS NECESSARY CONVENTIONAL SUTURE IN COLORECTAL ANASTOMOSIS,

    Additional Manufacturer Narrative · 1

    (B)(4). DAMAGED CARTRIDGE THE ANALYSIS RESULTS SHOWED THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH ONE RELOAD PRESENT. THE RELOAD WAS RECEIVED FULLY FIRED, WITH THE WASHER UNCUT, AND WITH THE ANVIL AND WASHER DETACHED. IT SHOULD BE NOTED THAT TO RELOAD THE DEVICE, INSERT THE NEW RELOAD INTO THE METAL HOUSING AND SNAP INTO POSITION. THE TRACKS ON EACH SIDE OF THE RELOAD SHOULD BE USED AS GUIDES TO ALIGN THE RELOAD WITHIN THE JAWS OF THE INSTRUMENT. WHEN THE RELOAD IS PROPERLY ALIGNED, PUSH THE RELOAD INTO THE INSTRUMENT UNTIL IT IS FULLY SEATED. REMOVE THE STAPLE RETAINER. CHECK THAT THE RELOAD IS HELD FIRMLY WITHIN THE JAWS. IF THE RELOAD IS REMOVED FROM THE DEVICE, WHETHER THE RELOAD IS SPENT OR NOT, AND IF THE STAPLE RETAINER HAS ALREADY BEEN REMOVED FROM THE RELOAD, THE RELOAD CANNOT BE RELOADED INTO THE DEVICE. PLEASE REFERENCE THE INSTRUCTIONS FOR USE FOR ADDITIONAL INFORMATION. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT AND FORMED THE STAPLES 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. AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, THE CONTOUR STAPLED JUST ONE BORDER, BUT THE OTHER ONE WAS DISMISSED. MANUAL STAPLING WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER TO REPORT THAT A TITANIUM ADAPTER HAD BEEN DETACHED FOUR TIMES SINCE (B)(6) 2009 WHEN THE PATIENT BEGAN PERITONEAL DIALYSIS (PD) THERAPY. THE TITANIUM ADAPTER HAS BEEN REPLACED AS A RESULT. NO PATIENT INJURY WAS REPORTED. CONSEQUENTLY, THE CENTER RETRAINED THE PATIENT, EXCLUDED THE USE OF DISINFECTANTS, REPLACED THE TRANSFER SET (B)(6) AND USED A DIFFERENT BATCH OF TRANSFER SET. AS A LAST RESORT, THEY REPLACED THE TITANIUM ADAPTER ON (B)(6) 2010. NO PROBLEMS OCCURRED AFTER REPLACING THE ADAPTOR. THE (B)(4) ASKED BAXTER TO INVESTIGATE WHETHER THERE WERE ANY DEVIATIONS IN THE SCREW THREAD OF THE TITANIUM ADAPTER. PER FOLLOW-UP INFORMATION RECEIVED ON (B)(6) 2010, THE PATIENT WAS PROPHYLACTICALLY TREATED ONCE WITH ANTIBIOTICS (DATE UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR CURVED CUTTER STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA G4RZ1X

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE