BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** ETS45

    MDR report key: 3150535 · Received June 6, 2013

    Report

    Report Number
    3005075853-2013-02860
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Report Date
    April 24, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INCOMPLETE-INTERRUPTED CYCLE. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: ON WHAT TISSUE TYPE WAS THE DEVICE USED? ASKU. AT WHAT LOCATION ON THE TISSUE? ASKU. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 8TH, ETC.) ASKU. WHAT COLOR CARTRIDGE WAS BEING USED? ASKU. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? ASKU. WAS BUTTRESSING MATERIAL UTILIZED? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? ASKU. WERE ANY UNEXPECTED NOISES HEARD? ASKU. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? YES, DURING FIRING. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? ASKU. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? NO. WHAT WERE THE PATIENT¿S PRE-EXISTING CONDITIONS? GALL BLADDER DISEASE. DOES THE PATIENT HAVE ANY RELEVANT HISTORY OF SURGICAL TREATMENTS? ASKU. HOW LONG HAS THE SURGEON BEEN USING THIS DEVICE FOR THIS PROCEDURE (IN YEARS)? 4+. WAS THERE A RECENT CONVERSION TO EES DEVICES IN THIS ACCOUNT OR WITH THIS SURGEON? NO. THE ANALYSIS RESULTS FOUND THAT DEVICE (A) WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A 6R45B RELOAD IN THE DEVICE. THE RETURNED RELOAD WAS PARTIALLY FIRED WHICH INDICATES THAT THE DEVICE'S FIRING CYCLE WAS INTERRUPTED. 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. PLEASE REFERENCE THE INSTRUCTION FOR USE FOR MORE INFORMATION. THE RETURNED DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT, AND ALL THE STAPLES FORMED 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. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. THE ANALYSIS SHOWED THAT DEVICE (B) WAS RECEIVED WITH THE FIRING MECHANISM DAMAGED AND WITH A RELOAD PRESENT. THE RELOAD WAS RECEIVED FULLY FIRED AND WITH THE RELOAD LOCK OUT SPRING BENT. THE DAMAGE TO THE RELOAD LOCKOUT SPRING IS CONSISTENT WITH DAMAGE OBSERVED WHEN ATTEMPTING TO FIRE AN ALREADY SPENT CARTRIDGE. THE RELOAD IS DESIGN TO LOCK OUT AFTER A PARTIAL OR COMPLETE FIRE TO AVOID RE FIRING A PARTIALLY OR FULLY SPENT RELOAD. FIRING THROUGH THE LOCKOUT MECHANISM CAN BREAK THE DEVICE. FOR MORE INFORMATION PLEASE REFER TO THE INSTRUCTIONS FOR USE. NO FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE FIRING TRIGGER TEETH WERE FOUND BROKEN. WHILE NO CONCLUSION COULD BE REACH WHAT CAUSE THE FIRING MECHANISM TO FAIL, IT IS POSSIBLE THAT THE DEVICE WAS FIRED ON TISSUE THICKER THAN INDICATED OR THROUGH A LOCKED CARTRIDGE. WHEN EITHER OR BOTH OF THESE SCENARIOS OCCUR THE COMPONENTS IN THE FIRING MECHANISM CAN BE DAMAGED. IT SHOULD BE NOTED THAT A 100% INSPECTION TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4). BATCH # J5JX06 (MFG DATE: 11/13/2012 EXP DATE: 10/13/2017). DAMAGED FIRING TRIGGER TEETH, DAMAGED SPRING CARTRIDGE LOCKOUT TAB.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE 1ST DEVICE WOULD NOT FIRE AT ALL. THE 2ND DEVICE WAS DIFFICULT TO FIRE. THE SAME DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251305 ENDOPATH** ETS45 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA J4CR94

    Patients

    Seq Age Sex Outcome Treatment
    1