BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 ARTICULATING

    MDR report key: 2854112 · Received December 3, 2012

    Report

    Report Number
    3005075853-2012-05422
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    October 22, 2012
    Report Date
    November 7, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANSWERS PROVIDED BY DR., RECEIVED FROM THE AFFILIATE: WERE THERE ANY ADVERSE CONSEQUENCES FOR THE PATIENT? (IF YES, PLEASE DESCRIBE). NO. HOW LONG WAS THE PROCEDURE PROLONGED? 20 MINUTES MORE. CAN YOU PLEASE CONFIRM THAT NO STAPLES WERE SEEN OR WERE THERE STAPLES PRESENT BUT NOT FORMED PROPERLY? THE STAPLES WERE PRESENT BUT MALFORMED. IF YES, WERE THEY UNFORMED , MALFORMED, PLEASE DESCRIBE THE SHAPE. THEY WERE PARTIALLY OPENED. ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE? ILEO ,IT WAS AN ILEO-ILEAL ANASTOMOSIS. WAS IT USED ON THICK TISSUE? NO. DID THE SURGEON WAITED THE RECOMMENDED 15 SECONDS AFTER CLOSING AND BEFORE FIRING THE DEVICE? YES. WAS THE CARTRIDGE CORRECT INSERTED, DID THEY HEAR THE "CLICK"? YES. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? FIRST AND SECOND CARTRIDGE. DURING WHICH STROKE DID THE EVENT OCCUR? AT THE END OF FOURTH STROKE. AFTER FEW MINUTES. WHAT COLOR CARTRIDGE WAS BEING USED? WHITE. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? NO. 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? WHAT WAS THE QUALITY OF TISSUE IN THE AREA WHERE THE DEVICE WAS FIRED? NO. WHAT WERE THE PATIENT'S PRE-OP DIAGNOSIS, DID HE/SHE SUFFERS FROM CANCER, MORBUS CROHN OR COLITIS ULCEROSA? NORMAL. IF APPLICABLE, DOES THE PATIENT HAVE A HISTORY OF RECEIVING RADIATION OR CHEMOTHERAPY OR A RELEVANT HISTORY OF SURGICAL TREATMENTS? IF SO, WHAT? NO BECAUSE HE WAS AN OBESE PATIENT. WHAT IS THE SEX OF THE PATIENT? MALE. WHAT IS THE CURRENT STATUS OF THE PATIENT? GOOD STATUS. HAS THIS ANY IMPACT ON THE PATIENT, THE SURGERY OR THE HEALING PROCESS? NO. THE ANALYSIS FOUND THAT ONE EC60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO CARTRIDGE RELOAD LOADED ON THE DEVICE. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. IT SHOULD BE NOTED THAT ALL DEVICES ARE INSPECTED 100% FOR STAPLE PRESENCE BY AN AUTOMATED VISION SYSTEM, AND ARE VISUALLY INSPECTED 100% AS A FINAL CHECK. IN ADDITION, AT FINISHED GOODS THE DEVICES ARE VISUALLY INSPECTED BASED ON A SAMPLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ILEOILEAL ANASTOMOSIS, THIS LINEAR CUTTER CUT BUT FAILED TO STAPLE. AS A CONSEQUENCE, THE SURGEON HAD TO APPLY SUTURES AND SURGERY TIME WAS PROLONGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 ARTICULATING STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4C29D

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR