BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 LONG

    MDR report key: 2243820 · Received September 12, 2011

    Report

    Report Number
    3005075853-2011-03758
    Event Type
    Malfunction
    Date Received
    September 12, 2011
    Date of Event
    August 19, 2011
    Report Date
    August 23, 2011
    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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT ONE LONG60A 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. EVENT COULD NOT BE CONFIRMED AS NO CARTRIDGE WAS RECEIVED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE REP THAT DURING A SLEEVE GASTRECTOMY PROCEDURE, AT THE FIRST FIRING ON THE THIRD STROKE THE HANDLE BECAME FLOPPY AND THE DEVICE LOCKED OUT. THE CUTLINE WAS FINE, BUT THE STAPLES WERE MALFORMED. THE MANUAL RELEASE WAS USED TO OPEN THE DEVICE. SUTURES AND CLIPS WERE USED TO CONTROL THE MINIMAL BLEEDING. THERE WAS NO TRANSFUSION NEEDED. ANOTHER DEVICE WITH A GOLD CARTRIDGE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE. THE CARTRIDGE WAS DISCARDED, BUT THE DEVICE IS AVAILABLE TO BE RETURNED FOR ANALYSIS. ON WHAT TISSUE TYPE WAS THE DEVICE USED? STOMACH. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? 1ST. DURING WHICH STROKE DID THE EVENT OCCUR? 3RD STROKE. WHAT COLOR CARTRIDGE WAS BEING USED? GOLD. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? NA. WAS BUTTRESSING MATERIAL UTILIZED? YES. IF SO, WHICH PRODUCT? PERI STRIPS. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO. WERE ANY UNEXPECTED NOISES HEARD? 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? NO. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? NO. PRIOR TO USING THE DEVICE THE RETAINING CAP WAS TAKEN OFF THE CARTRIDGE BEFORE LOADING IN THE DEVICE. IT TOOK TWO TRIES BEFORE THEY WERE ABLE TO LOAD THE CARTRIDGE INTO THE DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1