BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE*ILS CURVED CIR STAPL

    MDR report key: 1840070 · Received September 21, 2010

    Report

    Report Number
    3005075853-2010-05428
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 27, 2010
    Report Date
    August 30, 2010
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION. THE BREAKAWAY WASHER WAS PRESENT AND CUT AND THERE WERE NO STAPLES PRESENT, INDICATING THAT THE DEVICE ACHIEVED A FULL FIRING STROKE. THE DEVICE WAS RELOADED WITH STAPLES, A NEW WASHER WAS PLACED ON THE DEVICE AND IT WAS TESTED FOR FUNCTIONALITY. IT FIRED AND FORMED ALL THE STAPLES AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHER WITHOUT INCIDENT. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. 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.

    Additional Manufacturer Narrative · 1

    (B)(4) INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION: (B)(6).

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE CALCIUM RESULTS FOR PATIENT SAMPLES FROM THE INTEGRA 800 SERIAL NUMBER (B)(4). THE USER REPLACED THE REAGENT CASSETTE, PERFORMED CALIBRATION AND QUALITY CONTROL AND REPEATED THE PATIENT SAMPLES. OF THE DATA PROVIDED, THE RESULTS FOR TWO PATIENT SAMPLES WERE DISCREPANT. ALL RESULTS ARE IN MG/DL. PATIENT SAMPLE 1 INITIAL RESULT WAS 12.1 AND THE REPEAT RESULT WAS 11.0. PATIENT SAMPLE 2 WAS FROM A FEMALE BORN ON (B)(6). THE INITIAL RESULT WAS 12.1 AND THE REPEAT RESULT WAS 10.5. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND CORRECTED. NO TREATMENT WAS GIVEN TO THE PATIENTS DUE TO THE ERRONEOUS RESULTS. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A PROBLEM WITH THE REAGENT AND VERIFIED THE USER PUT ON FRESH CALCIUM REAGENT. TO VERIFY THE ANALYZER OPERATION, HE RAN PRECISION TESTING WITH ACCEPTABLE RESULTS AND THE USER RAN CALIBRATION AND QUALITY WITH ACCEPTABLE RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SIGMOID COLECTOMY PROCEDURE, THERE WERE NO STAPLES IN THE POSTERIOR RIGHT SIDE OF THE ANASTOMOSIS. SUTURES WERE USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE*ILS CURVED CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA G4T639

    Patients

    Seq Age Sex Outcome Treatment
    1