BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60

    MDR report key: 2061701 · Received April 18, 2011

    Report

    Report Number
    3005075853-2011-01556
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 29, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INDICATOR DISK THE SC60 DEVICE (A) WAS RETURNED WITHOUT A RELOAD AND THE VISUAL INSPECTION SHOWED THE 3-STROKE INDICATOR DISK WAS DAMAGED. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD. THE FUNCTIONAL TEST DEMONSTRATED THE DEVICE FIRED, CUT AND FORMED ALL STAPLES AS INTENDED. EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED AS INTENDED. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE INDICATOR DISK BECAME BROKEN, PLEASE NOTE THAT A 100% INSPECTION TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. THE SC60 DEVICE (B) WAS RETURNED WITHOUT A RELOAD AND THE VISUAL INSPECTION SHOWED THE 3-STROKE INDICATOR DISK WAS DAMAGED. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD. THE FUNCTIONAL TEST DEMONSTRATED THE DEVICE FIRED, CUT AND FORMED ALL STAPLES AS INTENDED. EVENT COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED AS INTENDED. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE INDICATOR DISK BECAME BROKEN, PLEASE NOTE THAT A 100% INSPECTION TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE WAS USED FOR LAPAROSCOPIC SEGMENTAL RECTUM RESECTION. WHEN THE DEVICE LOADING WAS FIRED, THE KNIFE DID NOT RETURN TO THE HOME POSITION AFTER THE THIRD STROKE OF THE SECOND FIRING. THE MANUAL RELEASE LEVER WAS PULLED UP, BUT THE KNIFE DID NOT RETURN TO THE HOME POSITION. WHEN THE FIRING TRIGGER WAS FULLY GRASPED AGAIN AND THE MANUAL RELEASE LEVER WAS PULLED UP SEVERAL TIMES, THE KNIFE RETURNED TO THE HOME POSITION AND THE JAW EVENTUALLY OPENED. THEN, THE SECOND DEVICE LOADING WAS FIRED, BUT THE FIRING LEVER DID NOT RETURN TO THE HOME POSITION. WHEN THE FIRING TRIGGER WAS FULLY GRASPED AGAIN AND THE MANUAL RELEASE LEVER WAS PULLED UP SEVERAL TIMES, THE KNIFE RETURNED TO THE HOME POSITION AND THE JAW BECAME TO BE OPENED EVENTUALLY. ANOTHER THIRD DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE ACRAL PARTS OF DEPLOYED STAPLES WERE UNFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK H4330D

    Patients

    Seq Age Sex Outcome Treatment
    1