BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 4241117 · Received November 10, 2014

    Report

    Report Number
    3005075853-2014-07792
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 22, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WHAT WAS MEANT BY MISFIRED? DID THE DEVICE DELIVER ANY STAPLES? IF YES, WERE THE STAPLES FORMED PROPERLY? IF YES, WAS THE STAPLE LINE COMPLETE? DID THE DEVICE CUT? IF YES, WAS THE CUT LINE COMPLETE? IF YES, WAS THERE ANY ISSUE WITH THE CUT LINE SUCH AS JAGGED, DULL KNIFE, IRREGULAR, ETC? HOW WAS THE PROCEDURE COMPLETED? ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING OR OPENING)?

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: ADDITIONAL INFORMATION RECEIVED: ONE DEVICE WOULD NOT OPEN AFTER FIRING. THE JAWS WERE EVENTUALLY OPENED. THE DEVICE WAS NOT ON TISSUE WHEN THIS OCCURRED. UPON REVIEW OF THE INFORMATION PROVIDED, IT WAS CONCLUDED THAT THIS EVENT DOES NOT MEET THE FDA DEFINED CRITERIA FOR A REPORTABLE EVENT, AND HAS BEEN REVISED TO NOT REPORTABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VATS PROCEDURE, BOTH STAPLERS LOCKED UP AND MISFIRE. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO ADDITIONAL INFORMATION WAS AVAILABLE. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723628 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4EY2N

    Patients

    Seq Age Sex Outcome Treatment
    1