BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60

    MDR report key: 1993603 · Received January 26, 2011

    Report

    Report Number
    3005075853-2011-00305
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    October 20, 2010
    Report Date
    October 29, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    PMA / PMN Number
    K015002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHROUD. EVAL SUMMARY: THE EC60 DEVICE WAS RETURNED WITH THE HANDLES OPEN AND WITH NO CARTRIDGE RELOAD PRESENT. 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. THE DEVICE OPENED AND CLOSED WITHOUT DIFFICULTIES. 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 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. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE SHROUDS BECAME DAMAGED; IT SHOULD BE NOTED THAT A 100% INSPECTION TAKES PLACE DURING MFG TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENTS, (B)(4). THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MFG PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE DEVICE WOULD NOT STAPLE AND WOULD NOT CUT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 GDW STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC NA G4TK30

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK