BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60 ENDOPATH

    MDR report key: 2991297 · Received March 6, 2013

    Report

    Report Number
    3005075853-2013-01085
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 8, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WHERE THERE STAPLES SEEN IN THE SURGICAL FIELD? IF STAPLES WERE SEEN IN THE SURGICAL FIELD, WHAT WAS THERE APPEARANCE? WHAT WAS THE AMOUNT OF BLOOD LOSS? DID THE PATIENT REQUIRE A BLOOD TRANSFUSION? ON WHICH STROKE DID THE EVENT OCCUR? WAS BUTTRESSING MATERIAL USED? IF YES, WHAT PRODUCT? WAS THE DEVICE FIRED OVER AN EXISTING STAPLE LINE? AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? WHAT IS THE CURRENT STATUS OF THE PATIENT? IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE?

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO HAVE DEVICE RETURNED. DEVICE LOCATION IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). INCOMPLETE-INTERRUPTED CYCLE, MISSING CARTRIDGE DRIVERS, CARTRIDGE PAN THE ANALYSIS RESULTS OF THE FOUND THAT IT WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH SEVEN RELOADS AS FOLLOWS: CARTRIDGE B, C AND D: ECR60D, J5JW84, FULLY FIRED, AND IN GOOD VISUAL CONDITION. CARTRIDGE E AND F: ECR60D, J5JW84, FULLY FIRED, WITH DRIVERS OUT OF POSITION. CARTRIDGE G: ECR60D, J5JW84, PARTIALLY FIRED 1/4; CARTRIDGE PAN, ONE PIECE SLED OUT OF POSITION AND SOME DRIVERS ARE MISSING. CARTRIDGE H: ECR60D, J5JW84, FULLY FIRED, CARTRIDGE PAN IS DETACHED AND SOME DRIVERS ARE MISSING. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS COMPLETE 3-STROKE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. THE CUT WAS NOTED TO BE JAGGED DUE TO A DAMAGED KNIFE. ONE POSSIBLE CAUSE FOR THIS TYPE OF DAMAGE TO THE KNIFE IS WHEN THE DEVICE IS FIRED OVER AN ALREADY EXISTING STAPLE LINE, HARD OBJECT OR THICKER TISSUE THAN INDICATED. REPEATEDLY FIRING ACROSS EXISTING STAPLE LINES CAN ALSO REDUCE THE ABILITY TO CUT CLEANLY. 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. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE PAN, DRIVERS AND ONE PIECE SLED BECAME DISLODGED FROM THE RELOADS, IT SHOULD BE NOTED THAT A 100% INSPECTION TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4) . 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 SLEEVE GASTRECTOMY PROCEDURE, THE DEVICE WOULD NOT STAPLE. THE THIRD CARTRIDGE WOULD NOT STAPLE BUT CUT PARTIALLY THE STOMACH. THE STAPLER AND THE CARTRIDGE ARE AVAILABLE FOR EVALUATION. THEY USED ANOTHER CARTRIDGE TO CLOSE THE STOMACH AND PERFORMED HEMOSTASIS WITH MANUAL SUTURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95373 ECHELON 60 ENDOPATH STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA J4CK60

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD-ECR60D