BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA XL 31MM SINGLE-USE STAPLER

    MDR report key: 1081719 · Received July 25, 2008

    Report

    Report Number
    1219930-2008-00557
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    June 30, 2008
    Report Date
    June 30, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: LOW ANTERIOR RESECTION. ACCORDING TO THE REPORTER: PT WITH RECTAL CANCER WITH HISTORY OF RECEIVING CHEMO-RADIATION DATE UNK. IN FOR LOW ANTERIOR RESECTION OF RECTUM WITH TAKEDOWN OF SPLENIC FLEXURE AND DIVERTING LOOP ILEOSTOMY FOR PROTECTIVE PURPOSES. DURING SURGERY, THE FOLLOWING EVENT OCCURRED, THE PROXIMAL COLON STAPLE LINE WAS EXCISED AND REPLACED WITH A HAND SEWN PROLENE PURSTRING AND THEN THE EEA STAPLER SIZERS WERE USED. A 31 SIZE WAS CHOSEN AS THIS WAS ADMITTED EASILY INTO THE PROXIMAL BOWEL AND APPEARED TO BE ADEQUATE FOR THE DISTAL RECTUM AS WELL. THE ANVIL WAS SECURED WITH THE PURSTRING WITHOUT INCIDENT, AND SOME EXTRANEOUS FATTY TISSUE EXCISED WITH CAUTERY FROM THE ANASTOMOTIC SURFACE. THEN, THE EEA STAPLER WAS PLACED BY FIRST ASSISTANT PER RECTUM AFTER GOING BELOW TO DO THIS. THIS WAS DONE UNDER DIRECT VISION THROUGH THE PELVIC SIDE AS WELL, GUIDING THE INSTRUMENT EASILY TO THE STAPLE LINE OF THE RECTAL STUMP, KEEPING THE VAGINAL WALL CLEARLY OUT TO THE AREA. THE STAPLER WAS DEPLOYED. THE ANVIL ATTACHED TO POST. THE STAPLER WAS CLOSED. ON DOING THIS, THERE SEEMED TO BE ABNORMAL TIGHTNESS TO THE STAPLER. APPARENTLY, IT WAS DIFFICULT TO WIND DOWN AND THE GREEN INDICATOR DESPITE BEING COMPLETELY CLOSED DID NOT SHOW GREEN. THE CO REP WAS IN THE ROOM AND THE RECOMMENDATIONS FOR THE DEVICE WERE QUITE STRICT REGARDING SHOWING GREEN IN THE INDICATOR BEFORE FIRING THE STAPLER. THE STAPLER WAS TIGHTENED FURTHER. AGAIN, IT SEEMED MORE DIFFICULT THAN AVERAGE TO REACH THIS POINT, AND FINALLY A SILVER OF GREEN WAS VISIBLE ON THE INDICATOR. THE STAPLER WAS THEN FIRED AND THERE APPEARED TO BE A COMPLETE ANASTOMOSIS. WHEN CHECKING FOR LEAKS, THERE APPEARED TO BE A BIG GAP POSTERIORLY IN THE STAPLE LINE. THE STAPLER FIRED ELSEWHERE INTACT ALL THE WAY AROUND. THERE WAS SOME DEGREE OF TENSION ON ANASTOMOSIS AS WELL DESPITE ASSESSING THIS BEFOREHAND, IT APPEARED ADEQUATE. SO, GIVEN STAPLER MALFUNCTION, THIS WAS SUBMITTED BACK TO THE CO FOR EVAL. THE ANASTOMOSIS WAS TAKEN DOWN AND RE-DONE. ADDITIONAL INFO RECEIVED STATES: DURING THE FIRING OF THE INSTRUMENT THE INSTRUMENT WAS DIFFICULT TO CLOSE. THE SURGEONS RE-OPEN THE INSTRUMENT TO CHECK THAT NOTHING WAS INCORPORATED IN THE JAWS. THEY THEN CLOSED IT AGAIN UNTIL GREEN WAS VISIBLE IN THE INDICATION EYE. THE INSTRUMENT WAS SUBSEQUENTLY APPLIED AND UPON REMOVAL IT WAS NOTED THAT THERE WAS AN INCOMPLETE PROXIMAL DONUT AND THE ANASTOMOSIS WAS INCOMPLETE. THE SURGEON THEN CUT OUT THE STAPLE LINE AND HAND SEWED THE ANASTOMOSIS. THERE WAS NO SERIOUS INJURY TO THE PT REPORTED. NO PERMANENT COLOSTOMY OR ILEOSTOMY AND NO BLOOD LOSS OCCURRED. THE SURGICAL TIME WAS EXTENDED BY APPROX ONE HOUR. THE PT IS IN WELL CURRENT CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA XL 31MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLER GDW NORTH HAVEN - USS U7C51

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention