BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX45 ARTICULATING

    MDR report key: 2200747 · Received August 11, 2011

    Report

    Report Number
    3005075853-2011-03251
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    June 27, 2011
    Report Date
    July 6, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. RECEIVED ADDITIONAL INFO FROM THE SALES REP: "THE PATIENT EXPERIENCED TISSUE TRAUMA" PLEASE DESCRIBE MORE IN DETAIL THE DIMENSION OF THE TISSUE TRAUMA. ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE? SMALL BOWEL (JEJUNUM) INSERTING THE CARTRIDGE. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? 5/6. DURING WHICH STROKE DID THE EVENT OCCUR? BEFORE FIRE. WHAT COLOR CARTRIDGE WAS BEING USED? BLUE/WHITE. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? BLUE. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? NO. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? NO. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? YES. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? NO. WHAT WAS THE QUALITY OF TISSUE IN THE AREA WHERE THE DEVICE WAS FIRED? HEALTHY. WHAT WERE THE PATIENT'S PRE-OP DIAGNOSIS, DID HE/SHE SUFFERS FROM CANCER, MORBUS CROHN OR COLITIS ULCEROSA? NO. IF APPLICABLE, DOES THE PATIENT HAVE A HISTORY OF RECEIVING RADIATION OR CHEMOTHERAPY OR A RELEVANT HISTORY OF SURGICAL TREATMENTS? IF SO, WHAT? WHAT IS THE AGE AND SEX OF THE PATIENT? UNKNOWN. WHAT IS THE CURRENT STATUS OF THE PATIENT? DISCHARGED. SURGEONS NOTICE SMALL BLEEDING FROM THE TISSUE AFTER STAPLER WAS REMOVED FROM LUMEN. IF IT WAS DUE TO THE STAPLING OF THE ANASTOMOSE ITSELF - OR THE FACT THAT SOME TISSUE MIGHT HAD A SMALL TEAR WHEN INTRODUCING THE CARTRIDGE INTO THE LUMEN OF JEJUNUM IS UNKNOWN. NO PROBLEM WAS RECORDED TO THE PATIENT AFTERWARDS. MINOR BLEEDING - NO TRANSFUSION OR BLOOD PRODUCTS NEEDED. TISSUE WAS RIPPED WHEN THE END-EFFECTER (CARTRIDGE SIDE) OF THE ECHELON WAS INTRODUCED INTO THE LUMEN OF THE JEJUNUM. THE SURGEON USED SUTURE TO CLOSE HOLE AND THE BLEEDING STOPPED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, WITH LINEAR STAPLING OF ANASTOMOSIS THE SURGEON NOTICED A HIGH RESISTANCE FROM TISSUE WHEN TRYING TO GET THE CARTRIDGE INTO THE LUMEN OF THE JEJUNUM. THE FIRST 1-1.5 CM OF CARTRIDGE SLIDE INTO OTOMY VERY EASY, BUT THEN FELT RESISTANCE FROM TISSUE. THE SURGEON SAID IT WAS LIKE TISSUE WAS HOLDING BACK THE INSTRUMENT. THE SURGEON HAD TO MOVE FORTH AND BACK AND THEN FINALLY GOT IT IN PLACE. THE SURGEON REPORTS THE FEELING IS THE SAME AS WHEN THE INSTRUMENT BY MISTAKE PERFORATES THE BOWEL WHICH IS VERY UNCOMFORTABLE. AS A RESULT OF THE DIFFICULTIES ENCOUNTERED WITH THIS DEVICE, THE PROCEDURE WAS PROLONGED FIVE MINUTES. THE PATIENT EXPERIENCED TISSUE TRAUMA. THE PATIENT WAS DISCHARGED IMMEDIATELY AFTER THE EVENT. THE CUSTOMER DISPOSED OF THE DEVICE AND THE RELOAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX45 ARTICULATING STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR45B