BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE CIRCULAR STAPLER

    MDR report key: 4092272 · Received September 16, 2014

    Report

    Report Number
    3005075853-2014-06436
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 21, 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
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WHAT PURSE STRING TECHNIQUE WAS USED OR WHAT PURSE STRING TECHNIQUE DOES THIS SURGEON NORMALLY USE? (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? WAS THE SPIKE OF THE TROCAR INSERTED LATERAL OR THROUGH THE STAPLE LINE? ON WHAT TISSUE TYPE WAS THE DEVICE USED? WHAT WAS THE QUALITY OF THE TISSUE? WAS THE DEVICE FIRED OVER THICK TISSUE, WAS IT EVENLY AND TENSION-FREE DISTRIBUTED IN THE INSTRUMENT? DID THE SURGEON WAITED THE RECOMMENDED 15 SECONDS AFTER CLOSING AND BEFORE FIRING THE DEVICE? WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? AFTER FIRING, DID THE FIRING HANDLE AUTOMATICALLY RETURN TO ITS ORIGINAL (PRE-FIRED) POSITION WITHOUT INTERVENTION? WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? IF YES, HOW MANY REVOLUTIONS OF THE ADJUSTING KNOB WERE USED TO OPEN THE DEVICE? WERE ANY ADDITIONAL STEPS TAKEN TO CONFIRM SUCCESSFUL ANASTOMOSIS (LEAK TEST, DONUT CONFIRMATION, ETC.)? IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE, PROCEDURE, PATIENT OR PHYSICIAN? 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. IT SHOULD BE NOTED THAT WHEN REMOVING THE DEVICE; OPEN THE INSTRUMENT BY TURNING THE ADJUSTING KNOB COUNTERCLOCKWISE. FOR EASY REMOVAL, ONLY OPEN THE INSTRUMENT ONE-HALF TO THREE-FOURTHS REVOLUTIONS. TO ASSURE THE ANVIL IS FREE FROM TISSUE, ROTATE THE INSTRUMENT 90° IN BOTH DIRECTIONS. TO WITHDRAW THE OPEN INSTRUMENT, GENTLY APPLY REARWARD TRACTION WHILE SIMULTANEOUSLY ROTATING. PLEASE REFERENCE INSTRUCTIONS FOR USE FOR ADDITIONAL INFORMATION NEEDED. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: ADDITIONAL INFORMATION RECEIVED: WHAT PURSE STRING TECHNIQUE WAS USED OR WHAT PURSE STRING TECHNIQUE DOES THIS SURGEON NORMALLY USE? (EX. HAND TIED PURSE STRING, PURSE STRING DEVICE) NONE. HOW WAS THE PURSE STRING PLACED, BY HAND OR WITH AN ASSIST DEVICE? IF AN ASSIST DEVICE, WHAT PRODUCT? NVT. WAS THE SPIKE OF THE TROCAR INSERTED LATERAL OR THROUGH THE STAPLE LINE? JUST CAUDAL OF STAPLES. ON WHAT TISSUE TYPE WAS THE DEVICE USED? WHAT WAS THE QUALITY OF THE TISSUE? RECTUM, GOOD WAS THE DEVICE FIRED OVER THICK TISSUE, WAS IT EVENLY AND TENSION-FREE DISTRIBUTED IN THE INSTRUMENT? NORMAL. DID THE SURGEON WAITED THE RECOMMENDED 15 SECONDS AFTER CLOSING AND BEFORE FIRING THE DEVICE? YES, BUT THE DEVICE DID NOT CLOSE PROPERLY. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? ?BUTTRESSING? WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? IRRELEVANT. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? I MISSED THE CLICK ON CLOSING. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? AFTER FIRING, DID THE FIRING HANDLE AUTOMATICALLY RETURN TO ITS ORIGINAL (PRE-FIRED) POSITION WITHOUT INTERVENTION? YES. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? IF YES, HOW MANY REVOLUTIONS OF THE ADJUSTING KNOB WERE USED TO OPEN THE DEVICE? YES, IT COULDN¿T BE REMOVED SINCE THE HOOD WAS NOT CUT PROPERLY. WERE ANY ADDITIONAL STEPS TAKEN TO CONFIRM SUCCESSFUL ANASTOMOSIS (LEAK TEST, DONUT CONFIRMATION, ETC.)? INTRAABDOMINAL INSPECTION, AND THE DEHISCENT ANASTOMOSIS WAS CLEARLY SEEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THEY HEARD THE CLICK OF THE ANVIL CONNECTING TO THE INSTRUMENT. THEY TURNED THE KNOB TILL THE THIRD LINE IN THE GREEN ZONE. THEY HEARD THE CLICK OF THE RING BUT EXPERIENCED DIFFICULTIES IN CLOSING THE HANDLE. THE HANDLE DID NOT TOUCH THE INSTRUMENT. THERE WERE ALSO PROBLEM WITH REMOVING THE INSTRUMENT OUT OF THE PATIENT. BY CHECKING THE DONUT THE WHITE RING WAS STILL ON THE SIDE OF THE ANVIL. THE STAPLES WERE NOT FORMED COMPLETELY AND THEREFORE THE STAPLE WAS STILL OPEN AND HAD TO CREATE A STOMA. THE ANVIL AND WHITE RING WERE DISCARDED. NO PICTURES OR MOVIE WAS MADE DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571063 PROXIMATE CIRCULAR STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4EX0J

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention