BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 ARTICULATING

    MDR report key: 2220131 · Received August 23, 2011

    Report

    Report Number
    3005075853-2011-03447
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    July 28, 2011
    Report Date
    August 1, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INSTRUMENT A: INCOMPLETE/INTERUPTED FIRING. INSTRUMENT B: BATCH # H51H1V, EXP DATE: 04/17/2016; MFR DATE: 05/17/2011; YOKE, PREMATURE SLED MOVEMENT. THE EC60A DEVICE (A) WAS RECEIVED FOR ANALYSIS WITH NO VISUAL NON-CONFORMANCES AND WITH AN ECR60D CARTRIDGE RELOAD PRESENT. THE CARTRIDGE RELOAD WAS RECEIVED PARTIALLY FIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION WITH THE RETURNED CARTRIDGE RELOAD BY RESETTING AND RELOADING IT INTO THE DEVICE. THE DEVICE ACHIEVED ITS COMPLETE STROKE 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. EVENT COULD NOT BE CONFIRMED AS NO STRANGE NOISE WAS HEARD DURING THE ANALYSIS. THE ANALYSIS FOUND THAT ONE EC60A DEVICE (B) WAS RETURNED WITH THE CLAMPING MECHANISM DAMAGED AND WITH AN ECR60D RELOAD PRESENT. THE RELOAD WAS RECEIVED PARTIALLY FIRED 1/10. IT IS POSSIBLE THAT WHILE LOADING THE RELOAD, THE CARTRIDGE WAS PUSHED FARTHER BACK THAN THE CARTRIDGE ALIGNMENT STOP WINDOWS RESULTING IN THE KNIFE PUSHING THE ONE PIECE SLED FORWARD AND LOCKING THE CARTRIDGE. THE RETURNED DEVICE AND CARTRIDGE RELOAD WERE TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION BY RESETTING AND RELOADING IT INTO THE DEVICE. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. HOWEVER, THE DEVICE WAS DISASSEMBLED TO VERIFY THE INTERNAL COMPONENTS AND THE YOKE WAS NOTED TO BE BROKEN. IT IS POSSIBLE THAT THE DEVICE WAS CLAMPED OVER AN EXCESS OF TISSUE OR A HARD OBJECT, RESULTING IN THE DAMAGE TO THE YOKE. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS; (B)(4). A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN PROCEDURE, THE FIRING TRIGGER OF THE DEVICE BECAME NOT TO BE GRASPED WITH A BREAKING SOUND AT THE 1ST STROKE WHEN IT WAS FIRED ON THE RECTUM AT THE 1ST FIRING. THE DEVICE WAS RELEASED BY USING THE MANUAL KNIFE REVERSE SWITCH. SOME STAPLES WERE FORMED B-FORMED SHAPE AND SOME STAPLES WERE UNFORMED. THE SAME EVENT OCCURRED IN BOTH EC60A. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION: ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE?---RECTUM. THE TARGET TISSUE WAS THICK. WAS THE DEVICE FIRED ON TISSUE THAT HAD BEEN RADIATED OR HAS THE PATIENT BEEN TAKING SYSTEMIC STEROIDS? ---NO INFORMATION. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? ---EACH DEVICE WAS NOT USED AFTER THIS EVENT. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? ---NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? ---NO. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? ---THE FORCE OF FIRING WAS HIGHER. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? ---YES. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? ---NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 ARTICULATING STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK NI

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60D