BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS FLEX ARTICNG LNR

    MDR report key: 3191362 · Received June 26, 2013

    Report

    Report Number
    3005075853-2013-03261
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 5, 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
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. ADDITIONAL INFORMATION RECEIVED PER TM: I MEET THE SURGEON AND HE TOLD ME, THEY HAD TO CONVERT TO OPEN PROCEDURE BUT NOT BECAUSE OF THE STAPLER. THEY CONVERTED BECAUSE OF THE TUMOR AND DIFFICULTY TO DISSECT BEFORE THEY STAPLED THE BOWEL. (THE NURSE WHO REPORTED TO ME MISUNDERSTOOD WHY THEY HAVE TO CONVERT ) ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE? RECTUM IN SMALL PELVIS. WAS IT USED ON THICK TISSUE? MAYBE LITTLE BIT THICKER THAN USUAL. 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. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO. 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. WHAT WAS THE PATIENT¿S PRE-OP DIAGNOSIS? RECTAL CANCER. PLEASE PROVIDE THE PATIENT¿S SEX, AGE AND WEIGHT. MALE, (B)(6) YEAR, BMI 25,5 WHAT IS THE CURRENT STATUS OF THE PATIENT? NO PROBLEM EVERYTHING IS OK. WAS THE DECISION TO CONVERT TO OPEN PROCEDURE ONLY CAUSED BY THE DIFFICULTIES WITH THE DEVICE? OR WERE THERE OTHER CIRCUMSTANCES, PATIENT CONDITIONS OR SURGEON¿S PREFERENCES THAT MAY HAVE CAUSE THE ADDITIONAL TIME? IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE? THE SURGEON NOTICED IT WAS LITTLE BIT HARDER TO CLOSE THE CONTOUR STAPLER ( GREEN RELOAD ), BUT THE STAPLERS FORMED CORRECT AND THEY INSPECTED THE STAPLELINE AND IT WAS OK. THE ANALYSIS RESULTS FOUND THAT THE ATS45 DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH TWO RELOADS PRESENT. THE RELOADS WERE RECEIVED FULLY FIRED AND IN GOOD VISUAL CONDITION. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED AND CUT WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE, THE CUT LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE EVENT COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED PROPERLY DURING TESTING. THIS REPORT IS NOT INTENDED TO DENY THAT YOU EXPERIENCED A PROBLEM WITH THE DEVICE. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LAPAROSCOPIC COLORECTAL PROCEDURE THE ENDOCUTTER WORKED FINE DURING THE TWO FIRST FIRINGS (FIRST TO TRANSECT THE VESSEL = TR45W AND SECOND FIRING ON THE BOWEL = 6R45B). WHEN THE SURGEON FIRED THE THIRD TIME WITH 6R45B, HE NOTICED THAT STAPLERS WERE FIRED BUT NOT FORMED CORRECT WHEN HE INSPECTED THE STAPLE LINE AND THERE WAS LEAKAGE. THERE WAS NO PROBLEM DURING THE FIRING CYCLE. THEY HAD TO CONVERT TO AN OPEN PROCEDURE AND USED A CONTOUR STAPLER TO STAPLE DISTALLY IN PELVIS (ANTERIOR RESECTION). EVERYTHING WENT FINE AND THE PATIENT IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291434 ETS FLEX ARTICNG LNR STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK K4CJ3X

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR 6R45B LOT# J4AL8Y