BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE ILS STAPLER

    MDR report key: 3910212 · Received July 2, 2014

    Report

    Report Number
    3005075853-2014-04604
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WHAT DEVICE WAS USED FOR THE PROXIMAL AND DISTAL TRANSACTION? WHAT COLOR RELOAD? HOW WAS IT CONFIRMED THAT ALL OF THE DESIRED TISSUE WAS CAPTURED? 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). HOW WAS THE PURSE STRING PLACED, BY HAND OR WITH AN ASSIST DEVICE? IF AN ASSIST DEVICE, WHAT PRODUCT? WERE THERE ANY PURSE STRING ISSUES? WHO DID THE PURSE STRING STEP? WAS THE SPIKE OF THE TROCAR INSERTED LATERAL OR THROUGH THE STAPLE LINE? WHAT CONFIRMATION DID THE SURGEON RECEIVE THAT THE ANVIL WAS FIRMLY ATTACHED? WHEN THE DEVICE WAS FIRED, WHERE WAS THE INDICATOR WITHIN THE GREEN ZONE/GAP SETTING SCALE? WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? HOW DID YOU CONFIRM THE DEVICE WAS FULLY FIRED (SUCH AS CRUNCH, COMPRESSED UNTIL UNABLE TO FIRE FURTHER, ETC.)? WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? IF YES, HOW MANY COUNTER-CLOCKWISE REVOLUTIONS WERE USED TO OPEN THE DEVICE? WHAT STEPS WERE TAKEN TO CONFIRM SUCCESSFUL ANASTOMOSIS? (SUCH AS LEAK TEST, DONUT CONFIRMATION, ETC.). DID THE OPERATION CHANGE SIGNIFICANTLY AS A RESULT OF THE DEVICE ISSUE? WHAT IS THE PATIENT¿S AGE AND SEX? WERE ANY UNFORMED OR MALFORMED STAPLES OBSERVED? WHEN WAS THE SAFETY RELEASED ON THE DEVICE? PRIOR TO BEING HANDED TO THE SURGEON? WAS THE DEVICE PRESENTED WITH THE ANVIL ON OR OFF OF THE DEVICE? IS IT CUSTOMARY FOR THE OR MANAGER TO ASSIST IN THE USE OF THE DEVICE? THE ANALYSIS RESULTS FOUND THAT THE CDH29A DEVICE ARRIVED WITH THE ANVIL MISSING, OTHERWISE IN GOOD VISUAL CONDITION. AS THE ORIGINAL ANVIL WAS NOT RECEIVED, FURTHER INVESTIGATION WITH THE ORIGINAL ANVIL COULD NOT BE PERFORMED. THE BREAKAWAY WASHER WAS NOT PRESENT AND THERE WERE NO STAPLES PRESENT. THE DEVICE WAS RELOADED WITH STAPLES, A NEW WASHER WAS PLACED ON THE DEVICE AND IT WAS TESTED FOR FUNCTIONALITY WITH A TEST ANVIL; IT FIRED AND 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. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: ADDITIONAL INFORMATION RECEIVED: HOW WAS IT CONFIRMED THAT ALL OF THE DESIRED TISSUE WAS CAPTURED? DONUTS INTACT WHAT PURSE STRING TECHNIQUE WAS USED OR WHAT PURSE STRING TECHNIQUE DOES THIS SURGEON NORMALLY USE IN HIS/HER LEFT COLON PROCEDURES? HAND TIED AND PLACED PROLENE PURSE STRING. HOW WAS THE PURSE STRING PLACED, BY HAND OR WITH AN ASSIST DEVICE? HAND. WERE THERE ANY PURSE STRING ISSUES? NO. WHO DID THE PURSE STRING STEP? SURGEON. WAS THE SPIKE OF THE TROCAR INSERTED LATERAL OR THROUGH THE STAPLE LINE? THROUGH OR RIGHT NEXT TO. WHAT CONFIRMATION DID THE SURGEON RECEIVE THAT THE ANVIL WAS FIRMLY ATTACHED? SURGEON PLACED RIGHT HAND UNDER DRAPS, LEFT HAND ON ANVIL. WHEN THE DEVICE WAS FIRED, WHERE WAS THE INDICATOR WITHIN THE GREEN ZONE/GAP SETTING SCALE? YES. ABSOLUTELY. WAS BUTTRESSING MATERIAL UTILIZED? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NEAR STAPLE LINE. HOW DID YOU CONFIRM THE DEVICE WAS FULLY FIRED (SUCH AS CRUNCH, COMPRESSED UNTIL UNABLE TO FIRE FURTHER, ETC.)? BOTH. AND IT CAME OUT NORMALLY AND EARLY. WERE ANY UNEXPECTED NOISES HEARD? NONE. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? NO. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? NONE. WHAT STEPS WERE TAKEN TO CONFIRM SUCCESSFUL ANASTOMOSIS? (SUCH AS LEAK TEST, DONUT CONFIRMATION, ETC.) UPPER COLON COMPLETELY CAME OFF LOWER PORTION (RECTALLY) TISSUE WAS CLEANLY CUT WITH NO STAPLES PRESENT. WERE ANY UNFORMED OR MALFORMED STAPLES OBSERVED? NONE WHEN WAS THE SAFETY RELEASED ON THE DEVICE? PRIOR TO BEING HANDED TO THE SURGEON? PRIOR TO FIRING ONLY. WAS THE DEVICE PRESENTED WITH THE ANVIL ON OR OFF OF THE DEVICE? ON. PLACED TRANSANALLY THEN ATTACHED. IS IT CUSTOMARY FOR THE OR MANAGER TO ASSIST IN THE USE OF THE DEVICE? OR MANAGER. FREQUENTLY ASSISTS IN THIS PROCEDURE ¿ WE HAVE DONE THIS TOGETHER FOR YEARS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SIGMOID COLON RESECTION PROCEDURE, THE DEVICE WAS CLOSED AND INSERTED. DEVICE WAS OPENED AND SURGEON HAD OR MANAGER CLOSE DEVICE IN GREEN RANGE. OR MANAGER STATED SHE HAD USED CDH29 DEVICE BEFORE BUT NOT THE CDH29A. DEVICE WAS FIRED BY SURGEON AND HE SAID THE FIRING FELT NORMAL AND GOOD TISSUE DONUTS WERE NOTED AS DEVICE CUT, HOWEVER NO STAPLES DEPLOYED. THE SURGEON COULD NOT FIND THE STAPLES. THERE WAS APPROXIMATELY 150 CC'S OF BLOOD LOSS AND NO BLOOD PRODUCTS WERE GIVEN. THE PATIENT RECEIVED A COLOSTOMY AND IT IS UNKNOWN IF PERMANENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386525 PROXIMATE ILS STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA J4A00U

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR