BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETS - ENDOSCOPIC LINEAR CUTTER (VASCULAR/THIN) - 35 MM

    MDR report key: 1253035 · Received December 4, 2008

    Report

    Report Number
    3005075853-2008-03490
    Event Type
    Injury
    Date Received
    December 4, 2008
    Date of Event
    November 3, 2008
    Report Date
    November 11, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 12/4/08. EVAL SUMMARY: THE ANALYSIS RESULTS FOUND THAT DEVICE A WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO RELOAD PRESENT ON THE DEVICE. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT AND FORMED THE STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE, THE CUT LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MFG PROCESS. THE ANALYSIS RESULTS FOUND THAT DEVICE B WAS RECEIVED STERILE AND IN GOOD VISUAL CONDITION AND WITH A RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED FULLY LOADED WITH STAPLES. THE DEVICE WAS OPENED AND TESTED FOR FUNCTIONALITY AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. EVENT DESCRIPTION COULD NOT BE CONFIRMED AS THE ORIGINAL DEVICE WAS NOT RETURNED FOR ANALYSIS. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MFG PROCESS. THE ANALYSIS RESULTS FOUND THAT DEVICE C WAS RECEIVED STERILE AND IN GOOD VISUAL CONDITION AND WITH A RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED FULLY LOADED WITH STAPLES. THE DEVICE WAS OPENED AND TESTED FOR FUNCTIONALITY AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MFG PROCESS. THE ANALYSIS RESULTS FOUND THAT TWELVE RELOADS WERE RECEIVED STERILE AND IN GOOD VISUAL CONDITION. ONE RELOAD WAS OPENED AND LOADED INTO A TEST DEVICE AND TESTED FOR FUNCTIONALITY AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MFG PROCESS. DEVICE B ADDITIONAL INFO: BATCH # E5PT47, EXPIRATION DATE: 7/2013 MFG DATE: 8/08. DEVICE C ADDITIONAL INFO: BATCH # E5PT47, EXPIRATION DATE: 7/2013, MFG DATE: 8/08. RELOADS ADDITIONAL INFO: BATCH # E5R89Y, EXPIRATION DATE: 8/2013, MFG DATE: 9/08.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A NEPHRECTOMY PROCEDURE, TWO VEINS WERE SEALED - ONE WITH THE DEVICE AND THE NEXT WITH A RELOAD. THE RELOADS WERE THROWN AWAY. THE VERY EXPERIENCED TWO SURGEONS SAW BOTH STAPLELINES AND THEY LOOKED NORMAL. THEY EXTRACTED THE SCOPE. BUT WHEN THEY REINTRODUCED IT, IT GOT COVERED WITH BLOOD. THEY CONVERTED IMMEDIATELY TO A OPEN PROCEDURE AND SAW THAT THE STAPLES ON ONE VEIN HAD APPARENTLY FALLEN OFF AND BLOOD WAS RUNNING OUT AT A VERY HIGH SPEED. DUE TO THEIR FAST REACTION, AND BLOOD TRANSFUSION THE PT SURVIVED. PT LOST 2.5 LITERS OF BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS - ENDOSCOPIC LINEAR CUTTER (VASCULAR/THIN) - 35 MM GDW ETHICON ENDO-SURGERY, LLC NA E4LV4L

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention TR35W