BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 3870500 · Received June 12, 2014

    Report

    Report Number
    3005075853-2014-03952
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 16, 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SENT. WHAT WAS THE BATCH/LOT NUMBER FOR THE DEVICE? 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? WHAT COLOR CARTRIDGE WAS BEING USED? WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING OR OPENING)?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN LOBECTOMY PROCEDURE, ON THE TWELFTH FIRING THE KNIFE BLADE WOULD NOT RETURN. EVENTUALLY STARTED WORKING WITH A LOT OF EFFORT. FIVE MINUTES DELAY TO SURGERY. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347837 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1