BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** ETS45 ENDOSCOPIC LINEAR CUTTER

    MDR report key: 3041350 · Received April 8, 2013

    Report

    Report Number
    3005075853-2013-01644
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 15, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION RECEIVED: ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE? PULMONARY VEIN AND PULMONARY ARTERY. WAS IT USED ON THICK TISSUE?NO NORMAL CONSISTENCY. DID THE SURGEON WAITED THE RECOMMENDED 15 SECONDS AFTER CLOSING AND BEFORE FIRING THE DEVICE? YES. WAS THE CARTRIDGE CORRECT INSERTED, DID THEY HEAR THE "CLICK"? THE SCRUB NURSE ASSURES ME SHE DID HEAR A CLICK AND THAT SHE WAS NOT UNDER TIME PRESSURE AND RUSHED TO RELOAD ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 8TH, ETC.) 5TH. WHAT COLOR CARTRIDGE WAS BEING USED? VASCULAR/WHITE. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? WHITE. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO. WERE ANY UNEXPECTED NOISES HEARD? NO. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? ON ALL OCCASIONS THE GUN WAS VERY STIFF AND 2 HANDS HAD TO BE USED. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? YES A PHOTO WAS RECEIVED OF A STAPLER CARTRIDGE. UPON REVIEW OF THE IMAGE, IT WAS CONCLUDED THAT THE POTENTIAL CAUSE OF THE REPORTED EVENT WAS THE RESULT OF AN INADVERTENT /ACCIDENTAL LOCK-OUT. THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH FIVE RELOADS PRESENT AND ONE LOADED IN THE DEVICE. RELOAD A WAS FULLY LOADED WITH STAPLES AND THE LOCKOUT SPRING NORMAL; RELOADS B, C, D, AND E WERE RECEIVED FULLY FIRED AND WITH THE LOCKOUT SPRING NORMAL, RELOAD F WAS RECEIVED PARTIALLY FIRED AND WITH THE LOCKOUT SPRING DAMAGED. THE DAMAGE TO THE RELOAD LOCKOUT SPRING IS CONSISTENT WITH DAMAGE OBSERVED WHEN THE FIRING CYCLE IS STARTED, INTERRUPTED, RELEASED, AND RESTARTED. WHEN FIRING THE DEVICE MAKE SURE THAT THE FIRING STROKE IS COMPLETED. DO NOT PARTIALLY FIRE THE DEVICE. FIRE THE DEVICE BY SQUEEZING THE FIRING TRIGGER COMPLETELY UNTIL IT RESTS ON THE CLOSING TRIGGER. ONCE THE FIRING CYCLE HAS BEEN INITIATED, IT MUST BE COMPLETED. IF RE-INITIATION OF FIRING IS RESUMED, THE DEVICE WILL LOCKOUT. FIRING THROUGH THE LOCKOUT MECHANISM WILL BREAK THE DEVICE. THE RETURNED DEVICE WAS TESTED FOR FUNCTIONALITY WITH THE RETURNED RELOAD (A) 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 NOTE TO HAVE THE PROPER B-FORMED SHAPE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HEART TRANSPLANT PROCEDURE THE SURGEON, FROM THE FIRST FIRING, THOUGHT THAT THE DEVICE WAS STIFF TO FIRE. THE GUN FIRED FOUR RELOADS, EACH FIRING FEELING STIFF. ON THE FIFTH FIRING THE STAPLES ONLY FIRED 1/3 ALONG THE RELOAD AND IT WAS NOT A GOOD CUT. THE PATIENT WAS ALREADY ON BYPASS SO THERE WAS NO LOSS OF CONTROL AND NO CONSEQUENCE TO THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143137 ENDOPATH** ETS45 ENDOSCOPIC LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4CR94

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR TSW45 (5)-F5UK7J