BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 4162011 · Received October 10, 2014

    Report

    Report Number
    3005075853-2014-06958
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 21, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION REQUESTED BUT UNAVAILABLE: WERE THERE ANY PATIENT CONSEQUENCES REPORTED? WHAT WAS THE CONDITION OF THE PATIENT FOLLOWING THE PROCEDURE ¿ STABLE, DISCHARGED, CRITICAL, PLEASE EXPLAIN. HOW WAS THE PROCEDURE COMPLETED? THE ANALYSIS FOUND THAT ONE PSE60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION. THREE ECR45B CARTRIDGE RELOADS WERE RETURNED FOR ANALYSIS. CARTRIDGE (C, D) L51R94, ECR45B, WERE RETURNED UNFIRED AND IN GOOD VISUAL CONDITIONS. CARTRIDGE (E) L51R94, ECR45B, WAS RETURNED UNFIRED. UPON FURTHER EVALUATION THE CARTRIDGE PAN WAS NOTED TO BE PARTIALLY DISLODGED AND WITH SEVERAL DRIVERS OUT OF POSITION. IT SHOULD BE NOTED THAT A 60MM DEVICE IS DESIGNED TO WORK ONLY WITH 60MM CARTRIDGES, FOR FURTHER LOADING INSTRUCTIONS PLEASE REFER TO THE ECHELON FLEX 60 POWERED IFU. DURING FURTHER EVALUATION, THE DEVICE WAS NOTED TO BE NON-FUNCTIONAL. IN ORDER TO EVALUATE THE CONDITION OF THE INTERNAL COMPONENTS THE DEVICE WAS DISASSEMBLED. UPON DISASSEMBLING, EVIDENCES OF CORROSION WERE NOTED ON THE MOTOR. PLEASE NOTE THAT 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. NO FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE RETURNED CONDITION OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, TWO UNITS OF THE SAME LOT # DID NOT FIRE ALONG WITH SOME RELOADS. IT IS UNKNOWN AT THIS TIME HOW PROCEDURE WAS COMPLETED. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643847 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK L4EJ6R

    Patients

    Seq Age Sex Outcome Treatment
    1