BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** ENDOSCOPIC

    MDR report key: 2150646 · Received July 6, 2011

    Report

    Report Number
    3005075853-2011-02772
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Report Date
    June 16, 2011
    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). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CHANNEL RETAINER. THE ANALYSIS RESULTS FOUND THAT THE (B)(4) DEVICE WAS RECEIVED WITH THE CLAMPING MECHANISM DAMAGED AND WITH NO CARTRIDGE LOADED IN THE DEVICE. NO FUNCTIONAL TEST WAS PERFORMED. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE SHROUD WAS FOUND BROKEN WERE ENGAGES WITH THE CHANNEL RETAINER. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW DAMAGE TO THE DEVICE OCCURRED, 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VIDEO ASSISTED THORACIC SURGERY PROCEDURE, AFTER FIRST RELOADING INCOMPLETE STAPLE LINE. 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 H43F4D

    Patients

    Seq Age Sex Outcome Treatment
    1