BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON*FLEX60 ARTICULATING

    MDR report key: 1953485 · Received January 10, 2011

    Report

    Report Number
    1527736-2011-00012
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 12, 2010
    Report Date
    December 14, 2010
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). KNIFE. THE ANALYSIS FOUND THAT ONE (B)(4) DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH TWO (B)(4) CARTRIDGE RELOADS PRESENT. THE CARTRIDGE RELOADS WERE RECEIVED FULLY FIRED. IN ADDITION, ONE GREEN STERILE RELOAD WAS RECEIVED FOR ANALYSIS. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. THE CUT WAS NOTED TO BE JAGGED DUE TO A DAMAGED KNIFE. ONE POSSIBLE CAUSE FOR THIS TYPE OF DAMAGE TO THE KNIFE IS WHEN THE DEVICE IS FIRED OVER AN ALREADY EXISTING STAPLE LINE, HARD OBJECT OR THICKER TISSUE THAN INDICATED. REPEATEDLY FIRING ACROSS EXISTING STAPLE LINES CAN ALSO REDUCE THE ABILITY TO CUT CLEANLY. TO MITIGATE THE POTENTIAL FOR STAPLES GETTING INTO THE CARTRIDGE AND INTERFERING WITH THE KNIFE PATH DURING DEVICE FIRING, PRIOR TO RELOADING THE DEVICE, RINSE THE ANVIL AND CARTRIDGE JAW IN STERILE SOLUTION AND THEN WIPE THE ANVIL AND CARTRIDGE JAW TO CLEAN ANY FORMED BUT UNUSED STAPLES FROM THE DEVICE. ADDITIONALLY, PROPER CARE SHOULD BE TAKEN WHEN PLACING THE DEVICE ON THE TISSUE TO BE STAPLED, TO ENSURE THAT NO HARD OBSTRUCTION SUCH AS A CLIP IS INCLUDED WITH THE TISSUE INSIDE THE JAWS. IT SHOULD BE NOTED THAT ALL DEVICES ARE INSPECTED 100% FOR STAPLE PRESENCE BY AN AUTOMATED VISION SYSTEM, AND ARE VISUALLY INSPECTED 100% AS A FINAL CHECK. IN ADDITION, AT FINISHED GOODS THE DEVICES ARE VISUALLY INSPECTED BASED ON A SAMPLE. THE RETURNED STERILE RELOAD WAS TESTED FOR FUNCTIONALITY WITH A TEST DEVICE AND ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC SLEEVE PROCEDURE, THE SURGEON USED THE DEVICE WITH THE GREEN RELOADS FOR THREE SUCCESSFUL TIMES ON THE STOMACH. ON THE FOURTH TIME, AFTER FIRING THE STAPLER, THE KNIFE CUT THROUGH THE STOMACH BUT WITHOUT STAPLING. THE STOMACH WAS CUT THROUGH ON BOTH SIDES BUT WITHOUT ANY STAPLES. THE SURGEON HAD TO OPEN THE PATIENT IN ORDER TO CONTINUE THE HAND SUTURING TO CLOSE THE STOMACH. THEN THE SURGEON OPENED THE DEVICE TO CONTINUE THE STAPLE LINE AFTER THE CUT PART. THE PATIENT WAS FOUND TO HAVE SOME ESOPHAGEAL TEARING (WHICH PROBABLY WAS NOT FROM THE STAPLER). THE STAFF CALLED FOR A THORACIC SURGEON WHO UNDERWENT A THORACOTOMY. THE CASE WAS PROLONGED TO SEVERAL HOURS. THE PATIENT WAS DISCHARGED TO THE ICU ON A VENTILATOR. SURGERY WAS PROLONGED SIX HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 ARTICULATING STAPLE, IMPLANTABLE GDW ETHICON ENDO SURGERY, INC (CINCINNATI) UNK G4U27T

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention (B)(4)