BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60 ENDOPATH

    MDR report key: 3173425 · Received June 17, 2013

    Report

    Report Number
    3005075853-2013-03082
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 1, 2013
    Report Date
    June 7, 2013
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT HAS BEEN DETERMINED THAT THIS INCIDENT WAS INITIALLY REPORTED BY THE AFFILIATE AND THE EVENT SUBMITTED UNDER MEDWATCH # 3005075853-2013-03227. THIS COMPLAINT HAS BEEN VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: ON WHAT TISSUE TYPE WAS THE DEVICE USED? LUNG AT WHAT LOCATION ON THE TISSUE? ASKU. WAS THE DEVICE FIRED ON TISSUE THAT HAD BEEN RADIATED OR HAS THE PATIENT BEEN TAKING SYSTEMIC STEROIDS? ASKU. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC)? ASKU. IF ECHELON, DURING WHICH STROKE DID THE EVENT OCCUR? ASKU. WHAT COLOR CARTRIDGE WAS BEING USED? GREEN. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? ASKU. WAS BUTTRESSING MATERIAL UTILIZED? NO. IF SO, WHICH PRODUCT? WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO. WERE ANY UNEXPECTED NOISES HEARD?NO. IF SO, WHEN? WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)?DIFFICULT TO FIRE. 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. IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE? NO. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. AS A LOT NUMBER WAS NOT RECEIVED, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOBECTOMY PROCEDURE, THE SURGEON FIRED THE DEVICE WITH A GREEN RELOAD ACROSS THE LUNG AND WHEN HE OBSERVED THE STAPLE LINE IT HAD ONLY FIRED ON ONE SIDE. HE STATED THAT THE DEVICE WAS DIFFICULT TO FIRE. HE WAS NOT TOLD WHICH SIDE OF THE STAPLE LINE DID NOT FORM. THE SURGEON THEN PROCEEDED BY SUTURING AT THAT SIDE AND CONTINUING WITH ANOTHER RELOAD. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274117 ECHELON 60 ENDOPATH STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD: ECR60G