BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 45 ENDOPATH

    MDR report key: 1981360 · Received February 8, 2011

    Report

    Report Number
    3005075853-2011-00499
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 13, 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
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE EC45 DEVICE WAS RETURNED WITH THE CLOSING TRIGGER AND ANVIL CLOSED. A RELOAD WAS RECEIVED LOADED ON THE DEVICE AND VOID OF STAPLES. UPON FURTHER INSPECTION OF THE DEVICE, TWO CLIPS WERE FOUND LODGED IN THE CARTRIDGE KNIFE SLOT PREVENTING THE KNIFE FROM RETURNING COMPLETELY AND THE ANVIL FROM OPENING. THE CLIP WAS REMOVED AND THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST CARTRIDGE RELOAD AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE CUT WAS NOTED TO BE JAGGED DUE TO A DAMAGED KNIFE. ONE POSSIBLE CAUSE FOR THE DAMAGED KNIFE MAY BE IF 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, 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. IT IS ALSO RECOMMENDED THAT 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. AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SPLENECTOMY PROCEDURE THE DEVICE AFTER FIRING DID NOT OPEN. THE DEVICE HAD TO BE REMOVED DISSECTING THE SPECIMEN. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 45 ENDOPATH STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G4RH3F

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD-ECR45W