BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROXIMATE ILS CIRCULAR STAPLER

    MDR report key: 3741006 · Received April 10, 2014

    Report

    Report Number
    3005075853-2014-02475
    Event Type
    Death
    Date Received
    April 10, 2014
    Date of Event
    March 25, 2014
    Report Date
    March 26, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INCOMPLETE FIRING CYCLE, UNCUT WASHER - BLEMISHED ADDITIONAL INFORMATION RECEIVED: WAS THE PROCEDURE DONE OPEN/LAPAROSCOPICALLY? OPEN. WHAT DEVICE WAS USED FOR THE PROXIMAL AND DISTAL TRANSACTION? WHAT COLOR RELOAD? THE PROXIMAL WAS A TLC55 WITH A BLUE RELOAD. THE DISTAL WAS A CONTOUR WITH A BLUE RELOAD. WHAT PURSE STRING TECHNIQUE WAS USED OR WHAT PURSE STRING TECHNIQUE DOES THIS SURGEON NORMALLY USE IN HIS/HER LEFT COLON PROCEDURES? (EX. HAND TIED PURSE STRING, PURSE STRING DEVICE). HE USED A HAND TIED PURSE STRING, WHICH I BELIEVE IS DR. (B)(6)¿ NORMAL TECHNIQUE. HOW WAS THE PURSE STRING PLACED, BY HAND OR WITH AN ASSIST DEVICE? IF AN ASSIST DEVICE, WHAT PRODUCT? PLACED BY HAND. WAS THE SPIKE OF THE TROCAR INSERTED LATERAL OR THROUGH THE STAPLE LINE? NO. WHAT CONFIRMATION DID THE SURGEON RECEIVE THAT THE ANVIL WAS FIRMLY ATTACHED? THE ALIGNMENT WAS CORRECT, AND ATTACHED BY HAND. WHEN THE DEVICE WAS FIRED, WHERE WAS THE INDICATOR WITHIN THE GREEN ZONE/GAP SETTING SCALE? YES. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NOT SURE. HOW DID YOU CONFIRM THE DEVICE WAS FULLY FIRED (SUCH AS CRUNCH, COMPRESSED UNTIL UNABLE TO FIRE FURTHER, ETC.)? THE SA COMPRESSED THE HANDLE OF THE DEVICE UNTIL UNABLE TO FIRE FURTHER. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? NO. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? NO, BUT THE AUDIBLE ¿CRUNCH¿ WAS VERY FAINT. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? IF YES, HOW MANY COUNTER-CLOCKWISE REVOLUTIONS WERE USED TO OPEN THE DEVICE? NO. ½ TURN CCW TO OPEN THE DEVICE. WHAT STEPS WERE TAKEN TO CONFIRM SUCCESSFUL ANASTOMOSIS? (SUCH AS LEAK TEST, DONUT CONFIRMATION, ETC.) COMPLETE DONUTS WERE CONFIRMED BY THE SURGEON. A SUBSEQUENT LEAK TEST SHOWED A LEAKY ANASTOMOSIS. DID THE OPERATION CHANGE SIGNIFICANTLY AS A RESULT OF THE DEVICE ISSUE? YES. THE PATIENT RECEIVED A DIVERTING COLOSTOMY. WHAT IS THE PATIENTS AGE AND SEX? N/A. DID A HCP OTHER THAN THE PRIMARY SURGEON FIRE THE INSTRUMENT? IF SO, WHOM? THE SURGEON¿S SA. WAS THERE A RECENT CONVERSION TO EES DEVICES IN THIS ACCOUNT OR WITH THIS SURGEON? YES, BOTH. WHAT KIND OF PARTIAL COLECTOMY? LAR. WERE ANY MALFORMED STAPLES OBSERVED UPON INSPECTION OF THE ANASTOMOSIS? N/A THE ANALYSIS RESULTS FOUND THAT THE CDH29A DEVICE ARRIVED IN GOOD VISUAL CONDITION. THE BREAKAWAY WASHER UNCUT AND INDENTED, INDICATING THAT THE DEVICE HAD NOT BEEN FIRED THROUGH A FULL FIRING STROKE OR POSSIBLY THAT THE ORANGE INDICATOR WAS NOT FULLY INTO THE SAFE GREEN FIRING RANGE. IT SHOULD BE NOTED THAT BEFORE FIRING THE DEVICE THE ORANGE INDICATOR SHOULD BE FULLY WITHIN THE GREEN RANGE OF THE GAP SETTING SCALE. IN ADDITION IT SHOULD BE NOTED THAT IF THE FIRING SEQUENCE IS NOT COMPLETE (THE FIRING HANDLE REACHES ITS STOPPING POINT, AND THE FIRING TRIGGER IS PARALLEL TO THE INSTRUMENT HANDLE) STAPLES COULD BE PARTIALLY DEPLOYED WITHOUT CUTTING THE WASHER. PLEASE REFERENCE THE INSTRUCTIONS FOR USE FOR ADDITIONAL INFORMATION. THE DEVICE WAS RELOADED WITH STAPLES AND TESTED FOR FUNCTIONALITY WITH A TEST WASHER; THE DEVICE FORMED ALL THE STAPLES, AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHER WITHOUT INCIDENT. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PARTIAL COLECTOMY, THE DEVICE WAS FIRED, DONUTS LOOKED GOOD BUT THERE WAS A LEAK IN THE ANASTOMOSIS. THE SURGEON THEN HAD TO GIVE THE PATIENT A COLOSTOMY. THE SURGEON STATED THAT IT IS UNKNOWN AT THIS TIME IF THE COLOSTOMY WILL BE TEMPORARY OR PERMANENT. HE WILL NOT KNOW FOR SEVERAL MONTHS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATES THAT THE PATIENT HAD COME TO THE EMERGENCY ROOM ON FRIDAY MAY 2 WITH UNSPECIFIED SYMPTOMS AND SUBSEQUENTLY DIED. ADDITIONAL FOLLOW UP IS BEING CONDUCTED. IF ADDITIONAL DETAILS BECOME AVAILABLE A 3500 A SUPPLEMENTAL WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217450 PROXIMATE ILS CIRCULAR STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4EA2T

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O TLC55, CS40B