BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 ARTICULATING

    MDR report key: 2063672 · Received April 19, 2011

    Report

    Report Number
    1527736-2011-00095
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 5, 2011
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K081146
    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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT THE EC60A DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITHOUT A RELOAD PRESENT. IN ADDITION A CARTRIDGE PAN WAS FOUND LODGE INSIDE THE CHANNEL. THE PAN WAS REMOVED FROM THE CHANNEL AND THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION AND FORMED ALL THE STAPLES AS INTENDED. THE FIRING CYCLE WAS COMPLETED AND THE KNIFE RETURNED AS INTENDED. 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 BECAME DISLODGE FROM THE RELOAD, IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, WHEN THE SURGEON USED THE DEVICE WITH THE FOURTH RELOAD THEN AT THE FOURTH FIRING, HE FIRED THE DEVICE AND AT THE FOURTH STROKE, THE DEVICE BLOCKED: THE BLADE DID NOT RETURN AT ITS INITIAL POSITION. THE STAPLE LINE COULD BE PERFORMED CORRECTLY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. FOR THIS PROCEDURE, FIVE GOLD RELOADS AND TWO WHITE RELOADS WERE USED. THE DEVICE (BUT WITHOUT ITS RELOAD) WILL BE RETURNED FOR ANALYSIS. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 ARTICULATING STAPLE, IMPLANTABLE GDW ETHICON ENDO SURGERY, INC (CINCINNATI) UNK H43F3R

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4)