BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 3941840 · Received July 17, 2014

    Report

    Report Number
    3005075853-2014-05049
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Report Date
    July 4, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. WHAT WAS THE APPEARANCE OF THE DEPLOYED STAPLES (IRREGULAR IN SHAPE, LEGS STRAIGHT)? WERE THERE ANY STAPLES MISSING FROM THE STAPLE LINE?

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: PROCEDURE: LAPAROSCOPIC RECTUM RESECTION. PATIENT¿S PRE-OP DIAGNOSIS: RECTUM CARCINOMA. TISSUE STATUS: NORMAL RECTUM TISSUE. FIRST FIRING OF EC60A FOR TRANSECTION OF THE RECTUM WITHOUT ANY ANOMALIES. STAPLE LINE WAS OK. THERE WAS A VERY SMALL TISSUE BRIDGE LEFT AND THE SURGEON DECIDED TO TAKE A SECOND RELOAD TO FINISH THE TRANSECTION. THERE WERE NO ANOMALIES DURING SECOND FIRING. AFTER REMOVING THE DEVICE SEVERAL UNFORMED STAPLES COULD BE OBSERVED BUT STAPLE LINE LOOKED COMPLETE. THERE WERE NO NEGATIVE CONSEQUENCES FOR THE PATIENT. PATIENT IS FINE. THE ANALYSIS FOUND THAT ONE EC60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH FOUR ECR60D CARTRIDGE RELOADS PRESENT. CARTRIDGE (A) L51W98, WAS RECEIVED FULLY FIRED AND LOADED ON THE DEVICE. CARTRIDGE (B) L51W98 WAS RECEIVED FULLY FIRED AND IN GOOD VISUAL CONDITION. FURTHERMORE, THE RETURNED RELOADS (A, B) WERE DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND NO ANOMALIES WERE NOTED; NO DAMAGE ON DECK WAS FOUND. CARTRIDGES (C, D) L51W98 WERE RECEIVED INSIDE THEIR STERILE PACKAGE AND IN GOOD VISUAL CONDITION. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION WITH THE RETURNED CARTRIDGE RELOADS (C, D) AND THEY ACHIEVED THEIR COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINES AND CUT LINES WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. THE EVENT COULD NOT BE CONFIRMED AS NO MALFORMED STAPLES WERE NOTED DURING FUNCTIONAL TESTING. UPON FURTHER INSPECTION THE JOINT COVER WAS NOTED TO BE TORN; THERE IS NO EVIDENCE THAT THERE IS ANY PORTION OF THE JOINT COVER MISSING. IT IS POSSIBLE THAT THE DEVICE WAS ATTEMPTED TO BE PULLED OUT FROM A TROCAR IN THE ARTICULATED POSITION, RESULTING IN THE EDGE OF THE TROCAR DAMAGING THE JOINT COVER. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC RECTUM PROCEDURE, MISFORMED STAPLES, NO FURTHER INFORMATION IS AVAILABLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419872 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4EC7Z

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD - ECR60D