BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29MM

    MDR report key: 1111065 · Received August 13, 2008

    Report

    Report Number
    3005075853-2008-01139
    Event Type
    Injury
    Date Received
    August 13, 2008
    Date of Event
    June 24, 2008
    Report Date
    June 26, 2008
    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
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 8/13/2008. EVAL SUMMARY: THE ANALYSIS RESULTS FOUND THAT ONE STERILE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. THE BREAKAWAY WASHER WAS PRESENT, UNCUT AND THE DEVICE WAS RECEIVED FULLY LOADED WITH STAPLES. THE DEVICE WAS OPENED AND TESTED FOR FUNCTIONALITY; THE DEVICE 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. THE ANVIL WAS PLACED ON THE DEVICE, CLOSED ON TICK FOAM AND THE ANVIL DID NOT UNSNAPPED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HARTMANS REVERSAL PROCEDURE, THE ANVIL WAS CONNECTED TO THE TROCAR AND IT CONNECTED FINE. UPON CLOSING THE DEVICE, THE SURGEON ENCOUNTERED A SIGNIFICANT AMOUNT OF RESISTANCE. THE SURGEON CONTINUED TO CLOSE IT AND AS SHE WAS TIGHTENING DOWN, THE RESISTANCE WENT TO ZERO. ANOTHER DEVICE WAS USED AND THE VAGINA WAS CAPTURED IN THE STAPLE LINE AS IT WAS SMALLER IN DIAMETER. NO MEDICAL INTERVENTION WAS REQUIRED TO RECTIFY THE SITUATION AND THE CASE WAS COMPLETED WITHOUT ANY PT CONSEQUENCE. THE PT WAS BROUGHT BACK TO THE OR FOR ADDITIONAL SURGERY. SHE HAD A FISTULA, OR MULTIPLE FISTULAS. SHE WAS TRANSFERRED TO ANOTHER FACILITY FOR FURTHER TREATMENT. THE ASSISTING SURGEON, INDICATED THAT THE DEVICE DID NOT MALFUNCTION, BUT THERE WAS A PROBLEM WITH EXCESSIVE TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29MM KOG ETHICON ENDO-SURGERY, LLC. NA C4FP86

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention