BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX45

    MDR report key: 3002355 · Received March 13, 2013

    Report

    Report Number
    3005075853-2013-01239
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 19, 2013
    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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? 1ST. ECHELON STRAIGHT/FLEX: FLEX. WHAT COLOR CARTRIDGE WAS BEING USED? BLUE. 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)? 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.

    Additional Manufacturer Narrative · 1

    (B)(4). JAMMED KNIFE. THE ANALYSIS FOUND THAT THE DEVICE WAS RECEIVED WITH THE CLOSING TRIGGER BROKEN AND WITH THE KNIFE JAMMED. IT IS POSSIBLE THE TRIGGER RESULTED BROKEN DUE TO APPLYING A LARGE PRYING FORCE IN THE OPENING DIRECTION. THE DEVICE WAS RECEIVED INSERTED THROUGH A TROCAR AND WITH AN ECR45B RELOAD PRESENT. THE RELOAD WAS RECEIVED FULLY FIRED AND IN GOOD CONDITION. DUE TO THE CONDITION OF THE DEVICE, NO FUNCTIONAL TEST COULD BE PERFORMED. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITIONS OF THE INTERNAL COMPONENTS AND NO ADDITIONAL ANOMALIES WERE NOTED. AFTER FURTHER ANALYSIS OF THE TUBE THE KNIFE WAS NOTED TO BE JAMMED DUE TO THE PRESENCE OF SEVERAL B-FORM STAPLES THAT WERE LODGED BETWEEN THE KNIFE AND THE ANVIL CHANNEL, RESULTING IN THE FIRING MECHANISMS JAMMING. TO MITIGATE THE POTENTIAL FOR STAPLES GETTING INTO THE CARTRIDGE AND INTERFERING WITH THE KNIFE PATH DURING DEVICE FIRING, PRIOR TO RELOADING THE DEVICE, 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 DEVICE. ADDITIONALLY, PROPER CARE SHOULD BE TAKEN WHEN PLACING THE DEVICE ON THE TISSUE TO BE STAPLED, TO ENSURE THAT NO HARD OBSTRUCTION SUCH AS A CLIP IS INCLUDED WITH THE TISSUE INSIDE THE JAWS. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE ON THE FIRST FIRING WITH A BLUE CARTRIDGE. THE DEVICE FIRED IN THE FLEX POSITION AND THE CUTLINE AND STAPLE LINE WERE COMPLETE. AFTER SEVERAL ATTEMPTS THE DEVICE WOULD NOT DE-ARTICULATE OF OPEN. ANOTHER SAME LIKE DEVICE WAS USED TO CUT THE DEVICE OFF TISSUE. THIS ADDED A FEW MINUTES TO THE PROCEDURE, BUT DID NOT AFFECT THE PATIENT'S OUTCOME OR THE OUTCOME OF THE PROCEDURE. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO FURTHER PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105373 ECHELON*FLEX45 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4C506

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60B, H43C5V