BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE ILS CURVED CIR STAPL

    MDR report key: 1983357 · Received February 10, 2011

    Report

    Report Number
    3005075853-2011-00528
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 14, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 02/10/2011. INFORMATION WAS NOT PROVIDED BY THE AFFILIATE. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION REQUESTED AND RESPONSE RECEIVED ON (B)(4) 2011. CONCERNING THE FIRST ATTEMPT TO USE THE DEVICE: (B)(6). CONCERNING THE SECOND ATTEMPT: (B)(6). THE CIRCULAR STAPLER SHOULD BE FIRED ONLY IF THE ORANGE INDICATOR IS WITHIN THE GREEN SAFE RANGE (IT WAS OK). ADDITIONAL INFORMATION PROVIDED TO AFFILIATE TO SHARE WITH CUSTOMER ON (B)(6) 2011: ACCORDING TO RESPONSE RECEIVED, DURING THE FIRST ATTEMPT TO USE THE DEVICE, THE SURGEON RELEASED THE SAFETY AND ATTEMPTED TO FIRE AS THE ANVIL OF THE CDH DISENGAGED. THIS EXPLAINS WHY THE DEVICE FAILED TO STAPLE DURING THE SECOND ATTEMPT TO USE THE INSTRUMENT. THE DEVICE CAN BE FIRED ONLY ONCE, SO FIRING THE DEVICE AGAIN WILL CUT THE TISSUE WITHOUT STAPLING IT. MOST LIKELY THE STAPLES WERE DEPLOYED DURING THE FIRST ATTEMPT TO FIRE. REQUEST CONTACT TO CUSTOMER AS SOON AS POSSIBLE AND EXPLAIN HIM THIS USE ERROR. THE DEVICE SHOULD BE FIRED AS SOON AS THE SAFETY HAS BEEN RELEASED. IF REPOSITIONING OF THE DEVICE IS REQUIRED AFTER HAVING RELEASED THE SAFETY, A NEW DEVICE SHOULD BE USED AS THE CIRCULAR STAPLER DOES NOT HAVE A LOCKOUT MECHANISM TO AVOID FIRING AN ALREADY USED DEVICE. ADDITIONAL INFORMATION REQUESTED AND RESPONSE RECEIVED ON (B)(6) 2011: THE SURGEON INFORMED US THAT HE CHECKED INTO THE PATIENT TISSUES IF THERE WAS ANY STAPLE (NO STAPLE WAS FOUND), BUT HE DID NOT CHECK INTO THE DEVICE. THIS DEVICE WILL BE RETURNED FOR ANALYSIS. (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(4). COLOR/DEFECT/VISUAL BLEMISH CORRECTED DATA: CATALOG # = CDH29A. THE ANALYSIS RESULTS FOUND THAT THE CDH29A DEVICE ARRIVED IN GOOD VISUAL CONDITION. THE ANVIL HALF BREAKAWAY WASHER WAS PRESENT AND CUT AND THERE WERE NO STAPLES PRESENT, INDICATING THAT THE DEVICE ACHIEVED A FULL FIRING STROKE; AFTER FURTHER ANALYSIS, THE GUIDE FACE AND THE WASHER HALF HAD SOME INDENTATIONS; THIS DAMAGE IS CONSISTENT WITH THE DEVICE BEING FIRED OVER AN ALREADY EXISTING STAPLE LINE, HARD OBJECT OR THICKER TISSUE THAN INDICATED. METAL CLIPS, STAPLES, OR SUTURES CONTAINED IN THE AREA TO BE STAPLED MAY AFFECT THE INTEGRITY OF THE ANASTOMOSIS. CORRECTIVE ACTION, IF REQUIRED, MAY INCLUDE THE USE OF SUTURES OR ELECTROCAUTERY. THE DEVICE WAS RELOADED WITH STAPLES, A NEW WASHER WAS PLACED ON THE DEVICE AND IT WAS TESTED FOR FUNCTIONALITY. THE DEVICE FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE STAPLE LINE WAS NOTED TO BE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE BATCH RECORDS WERE REVIEWED AND THE FINAL QUALITY RELEASE CRITERIA WERE MET BEFORE THE BATCHES WERE RELEASED FOR DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RECTUM PROCEDURE, THE DEVICE WOULD NOT STAPLE BUT CUT. REPAIRS TO THE RECTUM FOR CANCER BEING CURED, A SECTION-STAPLING ON THE MIDDLE-LOWER RECTUM. THE SURGEON CLIPPED THE ANVIL ON THE TROCAR, THE ANVIL DISENGAGED ITSELF THEN THE SURGEON HAD TO RE-CLIP IT. NORMAL COMPRESSION TISSUE, ORANGE INDICATOR WAS OK, THE RED SAFETY BACK HAD BEEN RELEASED CORRECTLY BUT WHEN THE SURGEON FIRED THE DEVICE HE DID NOT NOTICE THE TACTILE AND AUDIBLE FEEDBACK AS USUALLY (ONLY A DIFFUSE SOUND AND NOT 2 "CRACK"). THEN THE SURGEON PERFORMED AN AIR TEST AND NOTICED AIR BUBBLES CHARACTERISTIC OF POOR SEALING OF THE ANASTOMOSIS. AFTER CHECKING HE NOTICED THAT THE DEVICE HAD BEEN CUT BUT NOT STAPLED AND THE RECTAL STUMP HAD FALLEN INTO THE ABDOMINAL CAVITY. THE SURGEON CHECKED THE RECTUM AND COLON TISSUES AND DID NOT FIND ANY STAPLES. THE SURGEON HAD TO REMOVE THE PATIENT'S UTERUS TO RETRIEVE THE RECTAL STUMP AND PERFORMED THE ANASTOMOSIS WITH ANOTHER LIKE DEVICE (SAME LOT NUMBER) WITHOUT A PROBLEM. THE SURGEON DECIDED TO PERFORM A TEMPORARY PROTECTIVE ILEOSTOMY: THE PATIENT WAS AWARE BEFORE THE PROCEDURE THAT AN ILEOSTOMY COULD BE PERFORMED BECAUSE OF HER MEDICAL FILE AND BECAUSE OF THIS ADVERSE EVENT AND THE DIFFICULTIES OF THE PROCEDURE, THE SURGEON DECIDED TO DO THE ILEOSTOMY. THE PATIENT IS WELL AND WILL BE REVIEWED WITHIN EIGHT TO TEN WEEKS TO DETERMINE IF THE STOMA WILL BE MAINTAINED OR NOT. ADVISE THAT TO RETRIEVED THE RECTAL STUMP THE SURGEON HAD TO REMOVE THE UTERUS AND WHEN HE PERFORMED THIS CASE, THE SURGEON, ACCIDENTALLY, SECTIONED THE RIGHT URETER: THE SURGEON PERFORMED A DOUBLE MANUAL SUTURE WITH INTRODUCTION OF A "DOUBLE J" CATHETER INTO THE URETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE ILS CURVED CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA G4TY2P

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other| R