BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS LINEAR CUTTER

    MDR report key: 4090214 · Received September 15, 2014

    Report

    Report Number
    3005075853-2014-06422
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Report Date
    August 26, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT WAS THE ISSUE WITH 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? ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 8TH, ETC.)? WHAT COLOR CARTRIDGE WAS BEING USED? 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, FIRING, OR OPENING)? THE DEVICE WAS USED DURING A (B)(4) NEPHRECTOMY CASE: IT WOULDN¿T OPEN. ADDITIONAL INFORMATION WAS REQUESTED BUT UNAVAILABLE: THE DEVICE THAT WOULD NOT OPEN, HOW DID THEY REMOVE IT FROM THE TISSUE?

    Additional Manufacturer Narrative · 1

    (B)(4)ADDITIONAL INFORMATION: THE ANALYSIS RESULTS FOUND THAT THE ATS45 DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO RELOAD PRESENT ON THE DEVICE. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT AND FORMED THE STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE, THE CUT LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. EVENT COULD NOT BE CONFIRMED AS THE DEVICE CLOSED AND OPENED WITHOUT ANY DIFFICULTIES NOTED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THERE WAS AN ISSUE WITH THE DEVICE. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THE CALL. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS ANY PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568801 ETS LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1