BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOPATH*THOR

    MDR report key: 1911958 · Received December 1, 2010

    Report

    Report Number
    3005075853-2010-06774
    Event Type
    Death
    Date Received
    December 1, 2010
    Report Date
    November 3, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL FOLLOWUP WAS PROVIDED TO THE SALES REP FROM A SURGICAL ASSISTANT THE EVENT OCCURRED SOMETIME AT THE END OF OCTOBER. THE PATIENT WAS A MALE (B)(6). PATIENT WAS A BONE MARROW RECIPIENT AND HAD BEEN ON HIGH DOSE STEROIDS CAUSING POOR TISSUE CONDITION. THE PROCEDURE WAS A VATS, NO ABNORMALITIES WERE OBSERVED DURING THE INITIAL EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A SUPPLEMENTAL REPORT WILL BE SENT UPON RECEIPT OF FURTHER INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION RECEIVED FROM THE ACCOUNT CONTACT AND RISK MANAGEMENT: THE PATIENTS SURGERY WAS ACTUALLY ON (B)(6) 2010 AND HIS DEATH OCCURRED ON (B)(6) 2010 AFTER A THORACOSCOPIC RIGHT MIDDLE LOBECTOMY. THE PATIENT WAS FROM THE BONE MARROW TRANSPLANT UNIT AND HE HAD BEEN ON LONG TERM STEROIDS AND DID HAVE AN UNDERLYING FUNGAL INFECTION. THERE WAS AN AUTOPSY PERFORMED AND I DO NOT HAVE THE REPORT 'I AM NOT SURE WHO TO CONTACT' BUT I CAN DO THIS IF NEEDED. THE DR TOLD ME ABOUT THE PATIENT AND LET ME KNOW THAT THE PATIENT CAME THROUGH SURGERY SUCCESSFULLY AND WHILE COUGHING POST-OP ONCE HE RETURNED TO THE BONE MARROW UNIT HE HAD A SEPARATION OF THE BRONCHUS. THE STAPLE LINE WAS INTACT BUT BECAUSE OF POOR TISSUE INTEGRITY HE DID HAVE A TEAR. THERE WAS NO ISSUE WITH THE STAPLER. BASED ON THE ADDITIONAL INFORMATION PROVIDED, IT WAS CONCLUDED THAT THIS EVENT DOES NOT MEET THE FDA DEFINED CRITERIA FOR A COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE STERNUM SAW TO OPEN THE PT'S CHEST THE SAW WAS CUTTING IN A ZIG ZAG PATTERN INSTEAD OF STRAIGHT LINE. THERE WAS NO OTHER SAW AVAILABLE IN THE DEPARTMENT, SO THE SURGEON CONTINUED WITH THE SAW WHICH RESULTED IN A RAGGED EDGE TO THE STERNOTOMY. NO ADDITIONAL TREATMENT WAS GIVEN TO THE PT. THERE WERE NO REPORTS OF MEDICAL INTERVENTION PROVIDED TO PRECLUDE PERMANENT IMPAIRMENT.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT ONE TO TWO HOURS POST-OP OF A LOBECTOMY PROCEDURE, THE PATIENT EXPERIENCED A SEVERE COUGHING EPISODE WHICH CAUSED THE STAPLE LINE TO FAIL. THE PATIENT EXPIRED SOON AFTER, BUT EXACT DETAILS ARE NOT AVAILABLE AT THIS TIME. IT WAS MENTIONED THAT THE PATIENT WAS IN POOR HEALTH, ON HIGH DOSES OF STEROIDS, AND THE TISSUE QUALITY WAS POOR. NO PROBLEM WITH THE DEVICE WAS ENCOUNTERED DURING THE PROCEDURE. THE DEVICE WAS DISCARDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death