BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** ENDOSCOPIC

    MDR report key: 2173058 · Received July 23, 2011

    Report

    Report Number
    3005075853-2011-02952
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Report Date
    December 16, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): CHANNEL RETAINER DETACHED. INSTRUMENT B: BATCH #: G5070J, EXP DATE: 07/09/2015; DEVICE MANUFACTURE DATE: 08/09/2010 THE ANALYSIS RESULTS FOUND THAT THE EZ45B DEVICE (A) WAS RECEIVED WITH THE CLAMPING MECHANISM DAMAGED AND WITH A CARTRIDGE LOADED IN THE DEVICE. THE CARTRIDGE WAS RECEIVED PARTIALLY FIRED. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITIONS OF THE INTERNAL COMPONENTS AND CHANNEL RETAINER AND THE SHROUD WERE THE RETAINER ENGAGES WERE FOUND BROKEN. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE ANALYSIS RESULTS SHOWED THAT THE EZ45B DEVICE (B) WAS RECEIVED WITH THE CLAMPING MECHANISM DAMAGED AND WITH A CARTRIDGE PRESENT. THE CARTRIDGE WAS RECEIVED FULLY LOADED WITH STAPLES. NO FUNCTIONAL TEST WAS PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE CHANNEL RETAINER HOLDING FEATURES WERE FOUND BROKEN, NOT ALLOWING THE DEVICE TO PROPERLY CLOSE. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4) . A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VATS (VIDEO ASSISTED THORACIC SURGERY) PROCEDURE, THE DEVICE COULD NOT BE CLOSED CORRECTLY, NO FURTHER INFORMATION IS AVAILABLE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH** ENDOSCOPIC STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G4TNN99

    Patients

    Seq Age Sex Outcome Treatment
    1