BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOPATH STEALTH CIR STAPLER

    MDR report key: 1511267 · Received October 17, 2009

    Report

    Report Number
    3005075853-2009-06276
    Event Type
    Death
    Date Received
    October 17, 2009
    Date of Event
    September 1, 2009
    Report Date
    September 29, 2009
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    OCW
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 10/16/2009. INFO IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. EVALUATION SUMMARY: THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCES. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRIC BYPASS, THE DEVICE FIRED SUCCESSFULLY. THERE WAS DIFFICULTY REMOVING THE DEVICE AFTER THE ANASTOMOSIS USING THE RECOMMENDED INSTRUCTIONS FOR REMOVAL. THE DOUGHNUT WAS INTACT AFTER INSPECTION. THE SURGEON'S TECHNIQUE HAS NOT CHANGED. THE BUTTRESSING MATERIAL THAT THE SURGEON USES HAS CHANGED TO A SELF ADHESIVE MATERIAL FROM SYNOVIS. THE ANASTOMOSIS WAS OVER SEWN TO COMPLETE THE PROCEDURE. THE PT RETURNED TO SURGERY FOR LEAKING. THE PT EXPIRED. THE DEVICE WAS DISCARDED. RECEIVED THE FOLLOWING INFO ON 10/09/2009: PT SUFFERED A PULMONARY EMBOLISM POST OP AND THIS WAS THE CAUSE OF DEATH. THE ACCOUNT IS A LONG TIME USER OF EES CIRCULAR STAPLERS AND BUTTRESS MATERIAL FOR THE GASTROJEJUNAL ANASTOMOSIS AND RECENTLY (APPROX THE LAST THREE WEEKS) HAVE BEGUN USING A NEW SELF STICK ADHESIVE CIRCULAR BUTTRESS MATERIAL FROM SYNOVIS. SINCE THAT TIME, THEY'VE HAD DIFFICULTY OPENING THE DEVICE WHEN USING THE ADHESIVE. DURING THE PROCEDURE, DIFFICULTY WAS AGAIN ENCOUNTERED AND THE ANASTOMOTIC LIP WOULDN'T RELEASE, SO THE ANVIL COULD SLIDE THROUGH. WHEN CHECKING THE DONUTS, THE WASHER WAS NOT SEATED IN THE PROXIMAL PORTION OF THE STAPLER AS IT IS NORMALLY POSITIONED AFTER FIRING. INSTEAD, THE WASHER WAS NEAR THE DISTAL PORTION OF THE ANVIL. THE ADHESIVE WAS "VERY STICKY/GUMMY AND READILY STUCK TO A RUBBER GLOVE- IT WAS QUITE TACKY." FOLLOWING THIS PROCEDURE, THE SURGEONS DISCONTINUED USING THE ADHESIVE AND HAVE HAD NO FURTHER DIFFICULTIES WITH THE STAPLERS. RECEIVED THE FOLLOWING INFO ON 10/15/2009: [THE SURGEON] HAS NO THEORY AS TO WHY THIS PROBLEM IS OCCURRING. HE HAS SUBSEQUENTLY STOPPED USING THE SYNOVIS BUTTRESS MATERIAL AND HAS HAD NO FURTHER DIFFICULTIES. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH STEALTH CIR STAPLER OCW ETHICON ENDO-SURGERY, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R