BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 COMPACT

    MDR report key: 2212533 · Received August 16, 2011

    Report

    Report Number
    3005075853-2011-03317
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 22, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT ONE SC60A 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 (B)(4), 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 THE DEVICE WAS USED ON THE ILEUM. THE DEVICE LOADING A WHITE CARTRIDGE COULD BE FIRED WITHOUT ANY PROBLEMS TILL THE 2ND FIRING. AFTER THAT, THE DEVICE WAS USED FOR SIDE-TO-SIDE ANASTOMOSIS AT THE 3RD FIRING. WHEN LEAK TEST WAS PERFORMED, UNFORMED STAPLES OF THE ONE SIDE PARTIALLY (ABOUT 3CM AND THE PART SEEMED TO BE 2ND STROKE) FELL OUT FROM THE FIRED TISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE DOCTOR COMMENTED THAT HE HAD FELT A FEELING WHICH SOMETHING HAD SEEMED TO BE CAUGHT IN AT THE 4TH STROKE OF THE 3RD FIRING. ALTHOUGH THE CARTRIDGE WAS DISCARDED, ONE DEVICE WILL BE RETURNING. WHAT HAPPENED WITH THE SECOND FIRING?---THERE WAS NO PROBLEM TILL THE 2ND FIRING. LEAK OCCURRED FROM THE STAPLE LINE OF THE 3RD FIRING. DID THE DEVICE CUT COMPLETELY?---YES. ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE? ---ILEUM. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? ---3RD. DURING WHICH STROKE DID THE EVENT OCCUR? ---AFTER 4TH. WHAT COLOR CARTRIDGE WAS BEING USED? ---WHITE. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? ---WHITE. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? ---NO INFORMATION. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? ---THERE WAS A POSSIBILITY. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? ---NO INFORMATION. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? ---THE FORCE OF THE 4TH STROKE WAS A LITTLE HIGHER. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 COMPACT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK H43A8J

    Patients

    Seq Age Sex Outcome Treatment
    1