BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    75MM SELECTABLE NEW TLC

    MDR report key: 3113363 · Received May 15, 2013

    Report

    Report Number
    3005075853-2013-02326
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    March 28, 2013
    Report Date
    April 19, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K092577
    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). ADDITIONAL INFORMATION: WAS THE SURGEON AND O.R. STAFF THOROUGHLY IN-SERVICED ON THE STEPS OF USE PRIOR TO THE USE OF THE NTLC? YES. WAS THE SALES REP PRESENT DURING THE SURGEON'S FIRST FEW CASES TO INSURE THE INSTRUMENT WAS USED IN ACCORDANCE WITH THE IFU? YES. WAS THE REP PRESENT FOR THIS CASE? NO. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC)? ASKU. WHAT COLOR (BLUE/GOLD/GREEN) WAS SELECTED ON THE SELECTABLE STAPLE HEIGHT SELECTOR BEFORE FIRING? GOLD. WAS THE CARTRIDGE LOADED WITH THE RETAINING CAP ON? YES. WAS THERE AN ATTEMPT TO LOAD THE CARTRIDGE PROXIMAL END FIRST (LIKE AN ENDOCUTTER)? ASKU. DID ANYONE MOVE THE FIRING KNOB TO THE LEFT OR RIGHT AFTER LOADING THE DEVICE BUT BEFORE FIRING? NO. 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)? YES, FIRING. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? NO. DURING THE OPERATION, WHAT WAS THE APPEARANCE OF THE STAPLE LINE? MALFORMED STAPLES. WHAT WERE THE QUALITY AND/OR THICKNESS OF THE TISSUE IN THE AREA WHERE THE DEVICE WAS FIRED? REGULAR. WAS A LEAK TEST COMPLETED? ASKU. DID THE SURGEON WAIT 15 SECONDS AFTER CLAMPING AND PRIOR TO FIRING FOR OPTIMAL COMPRESSION? NO. IF THE DEVICE LOCKED OUT, DID IT LOCK OUT ON TISSUE OR PRIOR TO USE ON TISSUE? NA. WAS THERE AN INSPECTION OF THE STAPLE LINE ON BOTH SIDES OF THE TISSUE? YES, BUT FOUND MALFORMED STAPLES. WAS THE FIRING TO CLOSE AN OSTOMY? NO. IS A PATHOLOGY SPECIMEN AND/OR REPORT AVAILABLE? NO. WAS ANOTHER STAPLING DEVICE INVOLVED? YES, CDH. WHAT WERE THE PATIENT'S PRE-OP DIAGNOSIS AND/OR PRE-EXISTING CONDITIONS THAT COULD HAVE IMPACTED THE PATIENT'S HEALTH/SURGICAL OUTCOME? ASKU. HOW LONG HAS THE SURGEON BEEN USING THIS DEVICE FOR THIS PROCEDURE? 1+. WHAT PREDICATE DEVICE WAS USED BY THE SURGEON? TLC. WAS THERE A RECENT CONVERSION TO EES DEVICES IN THIS ACCOUNT OR WITH THIS SURGEON? NO. WHERE WAS THE LOCATION OF THE MALFORMED STAPLES - DISTAL, PROXIMAL OR IN THE MIDDLE OF THE STAPLE LINE? BOTH ENDS. WHERE THE MALFORMED STAPLES ON THE LINE CLOSEST TO THE CUT LINE OR IN ALL OF THE ROWS? ALL THE ROWS. WHERE THE STAPLE LEGS UNFORMED OR DID THEY HAVE IRREGULAR SHAPES? SHAPED OPPOSITE DIRECTION OF THE "B" FORM THE ANALYSIS RESULTS FOUND THAT THE CHANNEL HALF ONLY WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RETURNED FULLY FIRED. NO FUNCTIONAL TEST WAS PERFORMED. EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE ANVIL HALF OF THE DEVICE WAS NOT RETURN FOR ANALYSIS. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING AN OPEN COLON RESECTION PROCEDURE. THEY WERE ON THE SMALL BOWEL AND THE STAPLE LEGS WERE FORMED BACKWARDS, OPPOSITE OF THE "B" FORM. IT IS UNKNOWN IF SUTURES OR ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215259 75MM SELECTABLE NEW TLC STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4C0LP

    Patients

    Seq Age Sex Outcome Treatment
    1 SR75