BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH** ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM

    MDR report key: 2061770 · Received April 19, 2011

    Report

    Report Number
    3005075853-2011-01562
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 18, 2011
    Report Date
    April 1, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    KOG
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 04/19/2011. INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION REQUESTED AND THE FOLLOWING RESPONSE RECEIVED: (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(4). ANVIL_NOT RETURNED THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION AND WITHOUT THE ANVIL PRESENT. THE CASING HALF OF THE BREAKAWAY WASHER WAS PRESENT AND THERE WERE NO STAPLES PRESENT, INDICATING THAT THE DEVICE ACHIEVED A FULL FIRING STROKE. AS THE ANVIL WAS NOT RETURNED, A TEST ANVIL WAS USED TO PERFORM THE FUNCTIONAL TEST. THE DEVICE WAS RELOADED WITH STAPLES, A NEW WASHER WAS PLACED ON THE TEST ANVIL AND IT WAS TESTED FOR FUNCTIONALITY. IT FIRED AND FORMED ALL THE STAPLES AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHER WITHOUT INCIDENT. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. IT SHOULD BE NOTED THAT ALL DEVICES ARE INSPECTED 100% FOR STAPLE PRESENCE BY AN AUTOMATED VISION SYSTEM, AND ARE VISUALLY INSPECTED 100% AS A FINAL CHECK. IN ADDITION, AT FINISHED GOODS THE DEVICES ARE VISUALLY INSPECTED BASED ON A SAMPLE. EVENT COULD NOT BE CONFIRMED AS NO ANVIL WAS RECEIVED FOR ANALYSIS. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN COLON PROCEDURE, THE DEVICE WAS FIRED AND THERE WAS AN INCOMPLETE DONUT. IT IS UNKNOWN WHAT WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED. THERE ARE NO FURTHER DETAILS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH** ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM CIRCULAR STAPLERS KOG ETHICON ENDO-SURGERY, LLC. NA G4TH3D

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R