BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LONG 45 ENDOCUTTER

    MDR report key: 3121683 · Received May 21, 2013

    Report

    Report Number
    3005075853-2013-02442
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 1, 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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DAMAGED FIRING TRIGGER TEETH AND DAMAGED YOKE TEETH. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE? DORSAL VENOUS COMPLEX. WAS THE DEVICE FIRED ON TISSUE THAT HAD BEEN RADIATED OR HAS THE PATIENT BEEN TAKING SYSTEMIC STEROIDS? UNKNOWN. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC)? FIRST. IF ECHELON, DURING WHICH STROKE DID THE EVENT OCCUR? WHAT COLOR CARTRIDGE WAS BEING USED? BLUE. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? NONE. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? NONE. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO. WERE ANY UNEXPECTED NOISES HEARD? YES IF SO, WHEN? WHEN TRYING TO CLOSE (A LOUD CRACKING NOISE). WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? HIGHER WHEN TRYING TO CLOSE. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? WAS NOT USED BUT NO THEY DID NOT RETURN TO ORIGINAL POSITION. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? YES. STAPLER WOULD NOT OPEN NORMALLY BY PRESSING THE RELEASE BUTTON. THEY HAD TO PRY CLOSING TRIGGER FROM HANDLE IN ORDER TO OPEN JAWS. THE ANALYSIS RESULTS FOUND THAT DEVICE (A) WAS RECEIVED WITH THE FIRING AND CLAMPING MECHANISM DAMAGED; A RELOAD WAS LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED UNFIRED AND WITH THE LOCKOUT SPRING NORMAL. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS; THE FIRING TRIGGER TEETH AND YOKE TEETH WERE FOUND BROKEN. WHILE NO CONCLUSION COULD BE REACHED ON WHAT CAUSE THE DAMAGE TO THE DEVICE, IT IS POSSIBLE THAT THE DEVICE WAS ATTEMPTED TO CLOSE AND FIRE ON TICKER TISSUE THEN INDICATED OR ATTEMPTED TO FIRE THROUGH A LOCKED RELOAD IN PREVIOUS FIRINGS CAUSING AN INCREASE OF THE INTERNAL FORCES RESULTING IN THE COMPONENT YIELDING. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT FGQA. THE ANALYSIS RESULTS FOUND THAT DEVICE (B) WAS RECEIVED WITH THE FIRING AND CLAMPING MECHANISM DAMAGED; A RELOAD WAS LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED UNFIRED AND WITH THE LOCKOUT SPRING NORMAL. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS; THE FIRING TRIGGER TEETH AND YOKE TEETH WERE FOUND BROKEN. WHILE NO CONCLUSION COULD BE REACHED ON WHAT CAUSE THE DAMAGE TO THE DEVICE, IT IS POSSIBLE THAT THE DEVICE WAS ATTEMPTED TO CLOSE AND FIRE ON TICKER TISSUE THEN INDICATED OR ATTEMPTED TO FIRE THROUGH A LOCKED RELOAD IN PREVIOUS FIRINGS CAUSING AN INCREASE OF THE INTERNAL FORCES RESULTING IN THE COMPONENT YIELDING. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT FGQA. THE ANALYSIS RESULTS FOUND THAT DEVICE (C) WAS RECEIVED WITH THE FIRING AND CLAMPING MECHANISM DAMAGED; A RELOAD WAS LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED UNFIRED AND WITH THE LOCKOUT SPRING NORMAL. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS; THE FIRING TRIGGER TEETH AND YOKE TEETH WERE FOUND BROKEN. WHILE NO CONCLUSION COULD BE REACHED ON WHAT CAUSE THE DAMAGE TO THE DEVICE, IT IS POSSIBLE THAT THE DEVICE WAS ATTEMPTED TO CLOSE AND FIRE ON TICKER TISSUE THEN INDICATED OR ATTEMPTED TO FIRE THROUGH A LOCKED RELOAD IN PREVIOUS FIRINGS CAUSING AN INCREASE OF THE INTERNAL FORCES RESULTING IN THE COMPONENT YIELDING. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT FGQA. 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 ROBOTIC PROSTATECTOMY PROCEDURE, THE THREE STAPLERS WOULD NOT FIRE. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223868 LONG 45 ENDOCUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1