BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LONG 45 ENDOCUTTER

    MDR report key: 3190144 · Received June 26, 2013

    Report

    Report Number
    3005075853-2013-03284
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 6, 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). INFORMATION WAS NOT PROVIDED BY THE AFFILIATE. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: ON WHAT TISSUE TYPE WAS THE DEVICE USED? SMALL BOWEL AT WHAT LOCATION ON THE TISSUE? JEJUNUM. WAS IT USED ON THICK TISSUE? NORMAL. 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.) 7TH. WHAT COLOR CARTRIDGE WAS BEING USED? WHITE. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? BLUE AND WHITE. WAS BUTTRESSING MATERIAL UTILIZED? NO IF SO, WHICH PRODUCT? NA. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO. WERE ANY UNEXPECTED NOISES HEARD? NO IF SO, WHEN? NA. 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? OBESE WITH NO ADDITIONAL SURGICAL CONCERNS PLEASE PROVIDE THE PATIENT¿S SEX, AGE AND WEIGHT. FEMALE. WHAT IS THE CURRENT STATUS OF THE PATIENT? DISCHARGED. SINCE THERE WAS BLEEDING, IS IT POSSIBLE THAT THE PATIENT¿S HEALTH HISTORY OR ANATOMY CONTRIBUTED TO THE DIFFICULTIES THAT WERE ENCOUNTERED? NO. HOW MUCH BLOOD DID THE PATIENT LOST? UNSURE ¿ NOT MUCH WAS A TRANSFUSION REQUIRED? NO. WAS THE PATIENT TAKING ANY ANTICOAGULANTS? IF YES, SPECIFY PRESCRIBED MEDICATION. POST OP CLEXANE AS STANDARD. DOES PATIENT HAVE A KNOWN COAGULATION DISORDER? NO. HAS THE PATIENT TAKEN ANY STEROIDS? NO. WHAT WAS THE PATIENT¿S PRE-OP HEMOGLOBIN AND HEMATOCRIT? UNSURE. WHAT WAS THE PATIENT¿S POST OPERATIVE HEMOGLOBIN AND HEMATOCRIT? UNSURE. IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE? THE MAJOR CONCERN WAS THE OPEN ENDS OF BOWEL NOT THE BLEEDING (ALTHOUGH THIS WAS AN ISSUE). THE SUBSTANDARD STAPLE FORMATION LEFT 2 OPEN ENDS OF BOWEL, IF THEY HAD NOT BEEN IDENTIFIED BY THE SURGEON THE OUTCOME COULD HAVE BEEN CATASTROPHIC. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO RELOAD PRESENT ON THE DEVICE. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT AND FORMED THE STAPLES AS INTENDED. THE DEVICE FIRED 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. EVENT COULD NOT BE CONFIRMED AS NO CARTRIDGE WAS RECEIVED FOR ANALYSIS. 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 SLEEVE GASTRECTOMY PROCEDURE, THE DEVICE WAS LOADED WITH A WHITE RELOAD AND FIRED ACROSS THE JEJUNUM FOLLOWING THE J&J ANASTOMOSIS TO SEPARATE THE LIMB. THE RESULTANT STAPLE LINE WAS INCOMPLETE RESULTING IN 2 OPEN ENDS OF BOWEL. THE SURGEON SPENT SOME TIME TO STOP BLEEDING FROM OTHER AREAS OF THE STAPLE LINE AND AN ECHELON 60 FLEX WAS THEN USED TO STAPLE OFF THE ENDS OF OPEN BOWEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291014 LONG 45 ENDOCUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1