BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS FLEX ARTICNG LNR CUTR

    MDR report key: 2981461 · Received February 27, 2013

    Report

    Report Number
    3005075853-2013-00890
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 12, 2013
    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
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: ON WHAT TISSUE TYPE WAS THE DEVICE USED? APPENDIX. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 8TH, ETC.) 1ST FIRING. WHAT COLOR CARTRIDGE WAS BEING USED? BLUE. WAS BUTTRESSING MATERIAL UTILIZED? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? ASKU. WERE ANY UNEXPECTED NOISES HEARD? ASKU. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? ASKU. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? ASKU. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? ASKU. THE ANALYSIS RESULTS FOUND THAT THE ATS45 DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED FULLY FIRED AND WITH THREE MALFORMED STAPLES ON THE CARTRIDGE DECK. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED AND CUT 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. THE RETURNED CARTRIDGE WAS DISASSEMBLED AND NO ANOMALIES WERE FOUND ON ITS COMPONENTS. IN ADDITION, THE RETURNED RELOAD WAS DISASSEMBLED AND NO ANOMALIES WERE NOTED WITH THE INTERNAL COMPONENTS. THIS REPORT IS NOT INTENDED TO DENY THAT YOU EXPERIENCED A PROBLEM WITH THE DEVICE. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS. 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 A LAPAROSCOPIC APPENDECTOMY PROCEDURE THE STAPLE LINE DID NOT FORM. IT IS UNKNOWN IF THE DEVICE FULLY CUT. A SECOND DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84784 ETS FLEX ARTICNG LNR CUTR STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA J4CJ4G

    Patients

    Seq Age Sex Outcome Treatment
    1