BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX45

    MDR report key: 2183043 · Received July 28, 2011

    Report

    Report Number
    3005075853-2011-03081
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 25, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT ONE EC45A DEVICE WAS RETURNED WITH NO VISUAL NON-CONFORMANCES AND WITH A FULLY FIRED RELOAD PRESENT; HOWEVER SEVERAL B-FORMED STAPLES WERE FOUND ON THE DEVICE JAWS. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT AND ARTICULATED POSITIONS WITH A TEST RELOAD AND IT ACHIEVED A COMPLETE FIRE WITHOUT ANY DIFFICULTIES NOTED. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTE TO HAVE THE PROPER B-FORMED SHAPE. IT SHOULD BE NOTED THAT PRIOR TO RELOADING THE INSTRUMENT, RINSE THE ANVIL AND CARTRIDGE JAW IN STERILE SOLUTION AND THEN WIPE THE ANVIL AND CARTRIDGE JAW TO CLEAN ANY FORMED BUT UNUSED STAPLES FROM THE INSTRUMENT. DO NOT USE THE INSTRUMENT UNTIL IT HAS BEEN VISUALLY INSPECTED TO CONFIRM THERE ARE NO STAPLES ON THE ANVIL AND CARTRIDGE JAW. INSERT THE NEW RELOAD BY SLIDING IT AGAINST THE BOTTOM OF THE CARTRIDGE JAW UNTIL IT STOPS IN THE RELOAD ALIGNMENT SLOT. SNAP THE RELOAD SECURELY IN PLACE. REMOVE THE STAPLE RETAINING CAP AND DISCARD. THE INSTRUMENT IS NOW RELOADED AND READY FOR USE. ADDITIONALLY, PROPER CARE SHOULD BE TAKEN WHEN PLACING THE DEVICE ON THE TISSUE TO BE STAPLED, TO ENSURE THAT NO HARD OBSTRUCTION ARE INCLUDED WITH THE TISSUE INSIDE THE JAWS. FIRING THE DEVICE WITH HARD OBJECTS IN THE JAWS CAN JAM THE FIRING MECHANISM. EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE OPENED WITHOUT ANY DIFFICULTIES NOTED. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING A TRANSPLANT PNEUMONECTOMY. THE DEVICE WAS BEING FIRED OVER THE PULMONARY VEIN AND THE DEVICE LOCKED OUT ON 2ND FIRING, WOULD NOT FIRE, DURING LUNG REMOVAL. THE SURGEON STATED THE CASE WAS AROUND 3:30 IN THE MORNING AND TRIED TO DO THE CLEARING OF THE DEVICE BY PULLING THE HANDLES AND HITTING RELEASE BUTTON, BUT NOTHING WORKED. THE DEVICE WAS REMOVED BY CLAMPING ON THE PATIENT SIDE AND CUTTING THE DEVICE OFF THE VESSEL. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. ON WHAT TISSUE TYPE WAS THE DEVICE USED? VESSEL AT WHAT LOCATION ON THE TISSUE? RIGHT CHEST. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? 2ND FIRING. DURING WHICH STROKE DID THE EVENT OCCUR? LOCKOUT. WHAT COLOR CARTRIDGE WAS BEING USED? UNK. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? UNK. WAS BUTTRESSING MATERIAL UTILIZED? NO. IF SO, WHICH PRODUCT? NA. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? POSSIBLY NEAR A STAPLE LINE. 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? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX45 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK H43C85

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR45