BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS FLEX ARTICNG LNR CUTR

    MDR report key: 2770898 · Received October 3, 2012

    Report

    Report Number
    3005075853-2012-04522
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    September 12, 2012
    Report Date
    September 14, 2012
    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
    OR, 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. AT WHAT LOCATION ON THE TISSUE? UNK. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 8TH, ETC.) 1ST. WHAT COLOR CARTRIDGE WAS BEING USED? WHITE. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? WHITE. WAS BUTTRESSING MATERIAL UTILIZED? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO. WERE ANY UNEXPECTED NOISES HEARD? NO. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? NA. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? NA. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? NA. IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE? ANOTHER DEVICE WAS USED TO COMPLETE THE STAPLE LINE WHAT WERE THE PATIENT'S PRE-EXISTING CONDITIONS? APPENDICITIS. DOES THE PATIENT HAVE ANY RELEVANT HISTORY OF SURGICAL TREATMENTS? NO. HOW LONG HAS THE SURGEON BEEN USING THIS DEVICE FOR THIS PROCEDURE (IN YEARS)? UNK. WAS THERE A RECENT CONVERSION TO EES DEVICES IN THIS ACCOUNT OR WITH THIS SURGEON? NO. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A RELOAD PRESENT. THE RELOAD WAS RECEIVED FULLY LOADED WITH STAPLES. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH THE RETURNED RELOAD AND IT FIRED, CUT AND FORMED THE STAPLES AS INTENDED. IN ADDITION, A RELOAD FULLY FIRED AND IN GOOD VISUAL CONDITION WAS RECEIVED. THE CARTRIDGE WAS TAKEN OFF OF THE DEVICE AND PLACED BACK ON AND IT CLICK INTO PLACE. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING A LAPAROSCOPIC APPENDECTOMY. THE SURGEON WAS CUTTING ACROSS THE STRUCTURE AND THE DEVICE CUT BUT DID NOT STAPLE. THE SURGEON STATED IT FELT FUNNY, WHEN PULLING THE HANDLE AND KNEW HE COULD NOT HESITATE BUT WITH CONTINUED PRESSURE HE KNEW THAT IT WAS NOT FIRING CORRECTLY. NO TRANSFUSION OR BLOOD PRODUCTS WERE REQUIRED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS FLEX ARTICNG LNR CUTR STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA J4C36G

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4)