BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH** ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM

    MDR report key: 2013345 · Received March 10, 2011

    Report

    Report Number
    3005075853-2011-00971
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 16, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    KOG
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). USER FACILITY UNABLE TO LOCATE DEVICE REQUESTED.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION PROCEDURE, THE DEVICE WAS FIRED. WHEN THE DEVICE WAS REMOVED, THE DONUTS WERE NOT COMPLETE. THE SURGEON PERFORMED A LEAK TEST AND THE ANTERIOR SIDE OF THE STAPLE LINE BLEW OUT. SUTURES WERE USED TO OVER SEW THE ANTERIOR SIDE OF THE STAPLE LINE. THE SURGEON NOTICED THAT THE STAPLES ON THE ANTERIOR STAPLE LINE WERE NOT COMPLETELY FORMED. THE SURGEON PERFORMED ANOTHER LEAK TEST AND THE POSTERIOR SIDE OF THE STAPLE LINE BLEW OUT. THE CASE WAS CONVERTED TO OPEN. WHEN THE CASE WAS CONVERTED TO AN OPEN PROCEDURE, THE SURGEON NOTICED THAT THE STAPLES WERE NOT COMPLETELY FORMED ON THE POSTERIOR SIDE OF THE STAPLE LINE. A CONTOUR DEVICE WAS USED TO CREATE A NEW STAPLE LINE. ANOTHER CIRCULAR DEVICE WAS PULLED AND THE DEVICE FIRED AS INTENDED. A LEAK TEST WAS PERFORMED AND THERE WERE NO LEAKS DETECTED. AFTER THE PROCEDURE, THE PATIENT WAS STABLE. THE PATIENT DID NOT HAVE ANY PRE-EXISTING CONDITIONS SUCH AS CANCER, CHEMOTHERAPY OR RADIATION. THE ACCOUNT IS LOOKING FOR THE DEVICE, BUT MAY HAVE THROWN THE DEVICE AWAY AFTER THE PROCEDURE.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other| R