BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 COMPACT ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60 MM

    MDR report key: 2181794 · Received July 27, 2011

    Report

    Report Number
    3005075853-2011-03042
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.DEVICE NOT RETURNED. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. AS A LOT NUMBER WAS NOT RECEIVED, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ON WHAT TISSUE TYPE WAS THE DEVICE USED? VASCULAR. AT WHAT LOCATION ON THE TISSUE? SPLENIC HYLUM. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? 1ST. DURING WHICH STROKE DID THE EVENT OCCUR? 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. IF SO, WHICH PRODUCT? NA. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO. WERE ANY UNEXPECTED NOISES HEARD? NO. IF SO, WHEN? NA. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? NO. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? NO. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? NO. IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE? RELOAD WAS IMPROPERLY LOADED, NOT SNAPPED INTO PLACE. WHAT WERE THE PATIENT'S PRE-EXISTING CONDITIONS? TRAUMA CASE. ACCORDING TO THE SALES REPRESENTATIVE WHO WAS PRESENT IN THE CASE (AT THE HEAD OF THE PATIENT). PATIENT HAD MULTIPLE INJURIES DUE TO TRAUMA. THE TECH LOADED THE DEVICE, IT WAS FIRED ON THE SPLENIC VEIN AND ARTERY AFTER LITTLE DISSECTION, A SMALL AMOUNT OF BLEEDING (100CC'S) OCCURRED. THE DEVICE WAS REMOVED AND THE CARTRIDGE WAS IN THE PATIENT'S ABDOMEN. THE STAPLES WERE DEPLOYED BUT NOT IN TISSUE AND HAD POOR FORMATION, THE KNIFE HAD ADVANCED. THE DEVICE WAS SWISHED AND RELOADED UNDER SUPERVISION OF THE SALES REP AND NO ANOMALIES OCCURRED WITH ANY OTHER FIRINGS. PATIENT RECEIVED 4 UNITS OF PACKED RED BLOOD CELLS AND 2 FRESH FROZEN PLASMA DUE TO A SPLENIC LACERATION (UNRELATED TO THE DIFFICULTIES ENCOUNTERED WITH THE DEVICE). THE TECH WAS RE-INSERVICED AS WELL AS ALL OTHER TECHS. THE SURGEON HAS BEEN USING THE DEVICE FOR A LONG TIME AND HAS BEEN INSERVICED. THE PATIENT IS RECOVERING WELL AND HAS BEEN DISCHARGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING A EXPLORATORY LAPAROTOMY WITH SPLENECTOMY PROCEDURE. THE DEVICE'S RELOAD WAS IMPROPERLY LOADED. THE SURGEON PLACED THE DEVICE ON THE SPLENIC HYLUM AND FIRED, SURGEON THOUGHT IT CUT BUT NOT STAPLE, HOWEVER WHEN RELEASED THE CARTRIDGE WAS EJECTED INTO THE PATIENT, BUT WAS REMOVED. FOR THE SECOND FIRING, IT WAS NOTICED THAT THE TECH DID NOT SNAP RELOAD INTO PLACE. AFTER ADVISING TECH TO SNAP IN, ALL SUBSEQUENT FIRINGS WERE NORMAL. THERE WAS A TEAR NOTICED IN THE SPLENIC HYLUM, THE SURGEON STAPLED ACROSS AND WAS STILL SOME OOZING. THE AREA WAS SUTURED AND SUBSEQUENT FIRINGS WERE USED TO COMPLETE THE CASE. THE PATIENT LOST 100CC OF BLOOD. THERE WAS A TRANSFUSION GIVEN OF 4 UNITS OF PACKED RED BLOOD CELLS AND 2 FRESH FROZEN PLASMA. THE SURGEON STATED THIS WAS NOT DUE TO THE DEVICE INCIDENT. THE PATIENT HAD RECEIVED HEPARIN AT SOME POINT PRIOR TO THE PROCEDURE AND THE SURGEON STATED THIS MAY HAVE ATTRIBUTED TO THE OOZING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 COMPACT ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60 MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

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