BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60

    MDR report key: 2964224 · Received February 15, 2013

    Report

    Report Number
    3005075853-2013-00681
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 25, 2013
    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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INCORRECT CARTRIDGE SIZE. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WAS THERE TISSUE DAMAGE? IF YES, HOW WAS THE TISSUE REPAIRED? WAS THE DEVICE FIRED ON TISSUE THAT HAD BEEN RADIATED OR HAS THE PATIENT BEEN TAKING SYSTEMIC STEROIDS? ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC)? IF ECHELON, DURING WHICH STROKE DID THE EVENT OCCUR? WHAT COLOR CARTRIDGE WAS BEING USED? WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE? THE ANALYSIS RESULTS SHOWED THAT ONE EC60A DEVICE WAS RETURNED WITH NO VISUAL NON-CONFORMANCES AND WITH TWO RELOADS PRESENT. RELOAD (B) WAS RECEIVED FULLY FIRE; RELOAD (C) WAS A 45 MM RELOAD. THE RELOAD WAS NOTED TO BE UNFIRED. PLEASE NOTE THAT A 60MM DEVICE IS DESIGNED TO WORK ONLY WITH 60MM CARTRIDGES, FOR FURTHER LOADING INSTRUCTIONS PLEASE REFER TO THE ECHELON FLEX 60MM IFU. IT SHOULD BE NOTED THAT WHEN ATTEMPTING TO FIRE A 60MM DEVICE WITH A 45MM CARTRIDGE RELOAD, THE DEVICE WILL LOCK OUT; IN ORDER TO OPEN A LOCKED DEVICE A REVERSE STROKE NEEDS TO BE PERFORMED TRIGGER TO TRIGGER IN ORDER TO RETURN THE KNIFE TO THE HOME POSITION (INDICATOR IN THE "0" POSITION) AND PRESS THE ANVIL RELEASE BUTTON TO OPEN. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION WITH A 60 MM RELOAD AND IT ACHIEVED A COMPLETE FIRE SEQUENCE WITHOUT ANY DIFFICULTIES NOTED. THE DEVICE FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. EVENT COULD NOT BE CONFIRMED AS THE DEVICE OPENED AND CLOSED AS INTENDED. 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 SIGMOID COLECTOMY PROCEDURE, THE SURGEON TRIED TO FIRE THE DEVICE ACROSS THE VESSEL. THE GUN LOCKED OUT. IT WAS VERY DIFFICULT TO OPEN THE GUN. THE GUN WAS RELOADED WITH ANOTHER VASCULAR CARTRIDGE AND FIRED. FIRED FINE BUT WOULD NOT OPEN SUBSEQUENTLY. THE RELEASE BUTTON HAD TO BE "BASHED" HARD WITH THE HEEL OF THE HAND IN ORDER FOR THE JAWS TO OPEN. ON LOOKING AT THE CARTRIDGES, IT WAS DISCOVERED THAT THE FIRST VASCULAR CARTRIDGE WAS A 45MM HENCE THE REASON FOR THE GUN LOCKING OUT. THE SECOND CARTRIDGE WAS A 60 AND SO SHOULD NOT HAVE BEEN ANY DIFFICULTY IN OPENING THE JAWS HENCE IT IS BECAUSE OF THE SECOND FIRING THAT THE DEVICE IS BEING RETURNED. NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67070 ECHELON*FLEX60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1