BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH*STEALTH CIR STAPLER (EXACT CODE UNKNOWN)

    MDR report key: 3232521 · Received July 18, 2013

    Report

    Report Number
    1527736-2013-00037
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    May 27, 2013
    Report Date
    June 21, 2013
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY CONTACT. INFORMATION UNAVAILABLE. ADDITIONAL INFORMATION: FIRST SURGERY: WAS ANYTHING UNUSUAL NOTICED DURING THE FIRST SURGERY? NO. DID THE SURGEON OR ANYONE ELSE MENTIONED DIFFICULTIES WITH THE DEVICE DURING THAT SURGERY? NO. ON WHAT TISSUE TYPE WAS THE DEVICE USED? WHAT WAS THE QUALITY OF THE TISSUE? RECTUM, GOOD. WAS THE DEVICE FIRED OVER THICK TISSUE? NO, NORMAL TISSUE. DID THE SURGEON WAITED THE RECOMMENDED 15 SECONDS AFTER CLOSING AND BEFORE FIRING THE DEVICE? YES. WHAT CONFIRMATION DID THE SURGEON RECEIVE THAT THE ANVIL WAS FIRMLY ATTACHED TO THE TROCAR OF THE DEVICE? CLICK. WHEN THE DEVICE WAS FIRED, WHAT WAS THE LOCATION OF THE INDICATOR WITHIN THE GAP SETTING SCALE (TOP/THIN, MIDDLE/MEDIUM, BOTTOM/THICK)? IN GREEN. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO. HOW WAS IT CONFIRMED THAT THE DEVICE WAS FULLY FIRED (CRUNCH, LEVER COMPRESSED UNTIL UNABLE TO FIRE FURTHER, ETC.)? CRUNCH. WERE ANY UNEXPECTED NOISES HEARD? NO. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? NO. AFTER FIRING, DID THE FIRING HANDLE AUTOMATICALLY RETURN TO ITS ORIGINAL (PRE-FIRED) POSITION WITHOUT INTERVENTION? YES. DID THE RED SAFETY REMAIN ENGAGED UNTIL FIRING? YES. WAS THE TARGET TISSUE FULLY CUT CIRCUMFERENTIALLY? YES. WHAT WAS THE APPEARANCE OF THE BREAKAWAY WASHER? NORMAL. WAS THE BREAKAWAY WASHER COMPLETELY CUT THROUGH? YES. WERE THERE COMPLETE TISSUE DONUTS? YES. WHO FIRED THE DEVICE? SURGEON. HAS THE PERSON FIRING BEEN TRAINED ON HOW TO USE THE EES CIRCULAR DEVICE? YES. HAS THE O.R. STAFF BEEN TRAINED IN PREPARING THE EES CIRCULAR DEVICE? YES. WAS THERE A RECENT CONVERSION TO EES DEVICES IN THIS ACCOUNT OR WITH THIS SURGEON? NO. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? NO. WERE ANY ADDITIONAL STEPS TAKEN TO CONFIRM SUCCESSFUL ANASTOMOSIS (LEAK TEST, DONUT CONFIRMATION, ETC.)? DONUT CONFIRMATION. HOW WAS THE DEHISCENCE OF ANASTOMOSIS DETECTED? ACUTE ABDOMEN - PERITONITIS. DURING REOPERATION: REASONS FOR REOPERATION? DIFFUSED PERITONITIS. HOW WAS IT DETERMINED THAT PATIENT NEEDED TO GO BACK? DIFFUSED PERITONITIS. WHERE WAS THE LEAK? ANTERIOR SIDE OF THE ANASTOMOSIS. WERE STAPLES OBSERVED IN THE TISSUE? DO NOT RECALL WHAT DID THE STAPLE FORM LOOK LIKE? N/A. WERE ANY STAPLES PRESENT? N/A. DID THE ENTIRE STAPLE LINE OPEN UP? NO. HOW WAS THE ISSUE ADDRESSED? HARTMANN OP. WHY WAS COLOSTOMY PERFORMED? DUE TO PERITONITIS. IS THE COLOSTOMY TEMPORARY OR PERMANENT? TEMPORARY. DID THE PATIENT HAVE PRE-EXISTING CONDITIONS THAT COULD HAVE IMPACTED THE PATIENTS HEALTH/SURGICAL OUTCOME? AGE ¿ OLD PATIENT. WHAT PURSE STRING TECHNIQUE WAS USED OR WHAT PURSE STRING TECHNIQUE DOES THIS SURGEON NORMALLY USE? HAND TIED USED EXLUSIVELLY. WAS THE SPIKE OF THE TROCAR INSERTED LATERAL OR THROUGH THE STAPLE LINE? LATERAL, OUTSIDE STAPLE LINE. HOW THICK WAS THE TISSUE, WAS IT EVENLY AND TENSION-FREE DISTRIBUTED IN THE INSTRUMENT? NORMAL THICKNESS, YES. WAS THE ANVIL PUT ON THE TROCAR EXACTLY HORIZONTALLY? YES. PUTTING THE ANVIL ON THE TROCAR WERE ANY GRASPERS USED? NO, IT WAS PUT BY HAND. WAS THE DEVICE COMPLETELY FIRED PLASTIC TO PLASTIC? YES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON THE 5TH DAY FOLLOWING A SIGMOID RESECTION PROCEDURE DEHISCENCE OF ANASTOMOSIS PERFORMED WITH CIRCULAR STAPLER OCCURRED. REOPERATION WAS REQUIRED AND COLOSTOMY ESTABLISHMENT. DEVICE HAS BEEN DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334961 ENDOPATH*STEALTH CIR STAPLER (EXACT CODE UNKNOWN) LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO SURGERY, INC (CINCINNATI) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention