BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETS FLEX ARTICNG LNR CUTR

    MDR report key: 3153358 · Received June 8, 2013

    Report

    Report Number
    3005075853-2013-02885
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 17, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INCOMPLETE-INTERRUPTED CYCLE, DAMAGED SPRING CARTRIDGE LOCKOUT TAB. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE? SEE EVENT DESCRIPTION. WAS IT USED ON THICK TISSUE? TISSUE THICKNESS NORMAL, HOWEVER RECTUM WAS WIDE. WHAT WAS THE OUTCOME, LEAKAGE, BLEEDING OR OTHER PLEASE SPECIFY? LEAKAGE , STAPLE LINE INCOMPLETE, HALF OPEN, SEE EVENT DESCRIPTION. 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¿? YES. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 8TH, ETC.) SEE EVENT DESCRIPTION. WHAT COLOR CARTRIDGE WAS BEING USED? SEE EVENT DESCRIPTION. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? NONE. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? YES. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? NO. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? NO. 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. HOW OFTEN DOES THE SURGEON USE THIS DEVICE OR WAS THERE A RECENT CONVERSION TO EES DEVICES IN THIS ACCOUNT OR WITH THIS SURGEON? EXPERIENCED SURGEON, NO RECENT CONVERSION. THE ANALYSIS SHOWED THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A CARTRIDGE LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED PARTIALLY FIRED AND WITH THE RELOAD LOCK OUT 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. 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 FORMED ALL THE STAPLES 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION PROCEDURE, THE RECTUM WAS STAPLED WITH THE DEVICE WITH BLUE RELOADS (THIRD RELOAD). IT WAS A NARROW PELVIS AND THE DEVICE WAS PUT AT ITS MAX ARTICULATION. AFTER COMPLETE THE FIRING IT WAS NOTICED THAT THE STAPLE LINE WAS INCOMPLETE, THE RECTUM PARTIALLY OPEN ON BOTH SIDES. CONVERSION TO LAPAROTOMY AND MADE A SUTURE ANASTOMOSIS TO CONTROL TRANSECTION LINE BECAUSE IT WAS TOO LOW TO PUT ANOTHER STAPLE LINE UNDER THE FIRST ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258100 ETS FLEX ARTICNG LNR CUTR STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK K4CE7Z

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention RELOAD-6R45B