BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFETY LOCK-OUT - THICK

    MDR report key: 2227559 · Received August 30, 2011

    Report

    Report Number
    3005075853-2011-03586
    Event Type
    Death
    Date Received
    August 30, 2011
    Date of Event
    July 11, 2011
    Report Date
    August 10, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION: THE REP WAS CONTACTED BY THE CORONER TO ASK WHY HE WAS PRESENT DURING THE CASE. THE CORONER REPORTED THAT THE PATIENT DIED 3-4 DAYS POST OPERATIVELY DUE TO POST OPERATIVE LEAKAGE. THE REP WAS ASKED TO BE PRESENT FOR THIS CASE TO PROVIDE INSTRUCTION ON THE USE OF THE (B)(4). THE PROCEDURE BEGAN EARLIER THAN ORIGINALLY SCHEDULED, SO HE WAS ONLY PRESENT FOR THE LATTER PART OF THE CASE. DETAILS OF WHAT IS KNOWN ARE AS FOLLOWS: (B)(4) WITH GREEN RELOAD ((B)(4)) WAS USED FOR THE FIRST TWO FIRINGS. (B)(4) WAS FIRED TWICE: ONCE ON STOMACH AT THE BLUE SETTING. THE DEVICE WAS FIRED OVER AN EXISTING STAPLE LINE. THE REP CAME INTO THE CASE ON THE SECOND FIRING OF THE (B)(4). THE SECOND FIRING WAS ON SMALL INTESTINE AT THE BLUE SETTING. THE DEVICE WAS NOT FIRED OVER AN EXISTING STAPLE LINE FOR THIS FIRING. THE REP WAS ADVISED THAT FOR THE FIRST FIRING OF THE (B)(4), THE NURSE HAD REMOVED THE STAPLE RETAINING CAP PRIOR TO LOADING THE DEVICE. HE ADVISED THE NURSE NOT TO DO THIS ON THE SECOND FIRING AND WALKED THE NURSE THROUGH THE CORRECT LOADING SEQUENCE. THE RELOAD WAS CORRECTLY LOADED FOR THE SECOND FIRING; THE DEVICE WAS FIRED BY THE SURGEON. UPON INSPECTION OF THE STAPLE LINES, THE ASSISTANT SURGEON NOTICED A FEW SMALL HOLES WHERE THE BOWEL WAS ATTACHED TO THE STOMACH, THIS A SMALL GAP FROM THE CROTCH OF THE INSTRUMENT, NOT A GAP IN THE STAPLE LINE. THESE WERE SUTURED CLOSED. THERE WERE NO PROBLEMS REPORTED WITH THE FIRINGS PRIOR TO THE REP ENTERING THE CASE AND EVERYONE WAS HAPPY WITH THE OUTCOME. NO DETAILS ARE AVAILABLE AT THIS TIME ABOUT WHAT OCCURRED FOLLOWING THE SURGERY. WAS THE CARTRIDGE LOADED WITH THE RETAINING CAP ON? YES AND NO. DID THE SURGEON MOVE THE FIRING KNOB LEFT AND/OR RIGHT BEFORE FIRING? UNK. WAS THE HANDLE CLOSED COMPLETELY BEFORE FIRING? YES. WAS BUTTRESSING MATERIAL USED? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR EXISTING STAPLE LINE(S) OR CLIP(S)? YES. WERE ANY UNEXPECTED NOISES HEARD? NO. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, OPENING OR FIRING)? NO. DID ANY PART OF THE INSTRUMENT BREAK-OFF FROM THE DEVICE? NO. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM TISSUE? NO. DOES THE PATIENT HAVE ANY RELEVANT HISTORY OF SURGICAL TREATMENTS? UNK. HOW LONG HAS THE SURGEON BEEN USING THIS DEVICE FOR THIS PROCEDURE (IN YEARS)? 3 PREVIOUS FIRINGS. WHAT PREDICATE DEVICE WAS USED BY THE SURGEON? (B)(4). THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCES. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SALES REP SPOKE TO THE SURGEON WHO STATED THAT DURING THE REOPERATION, THE LEAK WAS AT THE CONTOUR STAPLE LINE. (REFER TO REPORT # 3005075853-2011-03584). CORRECTED DATA: UPON REVIEW OF ADDITIONAL INFORMATION, IT WAS CONCLUDED THAT THIS EVENT DOES NOT MEET THE FDA DEFINED CRITERIA FOR A REPORTABLE EVENT OR A COMPLAINT. (EVENT WAS INITIALLY REPORTED FOR TWO PRODUCT CODES, AS IT WAS NOT INDICATED WHICH STAPLE LINE LEAKED.)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3-4 DAYS FOLLOWING A GASTRECTOMY PROCEDURE, THERE WAS POST OPERATIVE LEAKAGE THAT LED TO THE PATIENT'S DEATH. TWO STAPLING DEVICES WERE USED DURING THE CASE AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE. THERE WAS NO EVIDENCE OF DEVICE PROBLEMS DURING THE PROCEDURE. THE DEVICES WERE DISCARDED FOLLOWING THE PROCEDURE. ADDITIONAL INFORMATION BEING REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFETY LOCK-OUT - THICK STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O CARTRIDGE