BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ILS CURVED CIR STAPL

    MDR report key: 1076836 · Received July 14, 2008

    Report

    Report Number
    1527736-2008-03854
    Event Type
    Malfunction
    Date Received
    July 14, 2008
    Report Date
    May 28, 2008
    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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER # = E5MY9J (BATCH # FOR DEVICES B & C), E5MH7A (BATCH # FOR DEVICES D, E, F, G, H & I), D5KL5G (BATCH # FOR DEVICES J, K & L), D5GZ4F (BATCH # FOR DEVICE M), D5LP42 (BATCH # FOR DEVICE N), D5KZ1A (BATCH # FOR DEVICE O) AND D5H68U (BATCH # FOR DEVICE P); EXP DATE = 07/2011 FOR DEVICES B & C, 01/2013 FOR DEVICES D, E, F, G, H & I, 08/2012 FOR DEVICES J, K & L, 12/2011 FOR DEVICE M, 11/2012 FOR DEVICE N, 09/2012 FOR DEVICE O AND 01/2012 FOR DEVICE P. 08/2006 FOR DEVICES B & C, 02/2008 FOR DEVICES D, E, F, G, H & I, 09/2007 FOR DEVICES J, K & L, 01/2007 FOR DEVICE M, 12/2007 FOR DEVICE N, 10/2007 FOR DEVICE O AND 02/2007 FOR DEVICE P. EVALUATION SUMMARY: DEVICE A 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. FIFTEEN STERILES DEVICES WERE REC'D AND ONE OF EACH BATCH WAS ANALYZED. DEVICE B FROM BATCH E5MY9J, DEVICE E FROM BATCH E5MH7A, DEVICE L FROM BATCH D5KL5G, DEVICE M FROM BATCH D5GZ4F, DEVICE N FROM BATCH D5LP42, DEVICE O FROM BATCH D5KZ1A AND DEVICE P FROM BATCH D5H68U. THE DEVICES WERE REC'D IN STERILE PACKAGES AND IN GOOD VISUAL CONDITION. THE BREAKAWAY WASHERS WERE PRESENT, UNCUT AND THE DEVICES WERE REC'D FULL Y LOADED WITH STAPLES. THE DEVICES WERE OPENED AND TESTED FOR FUNCTIONALITY; THE DEVICES FIRED AND FORMED ALL THE STAPLES AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHERS WITHOUT INCIDENT. THE STAPLE LINES WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. IN ADDITION, COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. 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 AN UNKNOWN PROCEDURE, THE ANASTOMOSIS WAS INCOMPLETE. THE STAPLES DID NOT HAVE A B-SHAPE. THE DEVICE CUT COMPLETELY. UNKNOWN HOW CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT. PATIENT IS FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1