BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH STEALTH CIR STAPLER

    MDR report key: 2212743 · Received August 16, 2011

    Report

    Report Number
    3005075853-2011-03320
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 25, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. 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 INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE ILLEOSTOMY WAS A PLANNED, TEMPORARY ILLEOSTOMY AND HAD NOTHING TO DO WITH THIS EVENT. THEREFORE, THIS EVENT NO LONGER MEETS THE CRITERIA OF AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR COLON RESECTION PROCEDURE, THE PURSE STRING WAS DONE ON THE PROXIMAL SECTION OF THE BOWEL AND THEN IT WAS NOTICED THAT THERE WERE A FEW DIVERTICULUM OF COLON. TWO ADDITIONAL SUTURES WERE DONE TO INCLUDE THE FEW DIVERTICULUM. THEN THE SURGEON ATTACHED THE ANVIL TO THE DEVICE. WHEN HE TRIED TO DETACH THE ANVIL FROM THE DEVICE, THE ANVIL WOULD NOT COME OFF. THE DEVICE HAD TO BE CUT OFF THE TISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE. THE PROXIMAL DONUT WAS NOT FULLY COMPLETE. A LEAK TEST WAS DONE AND THERE WERE NO LEAKS. THE SURGEON PERFORMED A PROTECTIVE TEMPORARY ILEOSTOMY. THE SURGEON WILL CHECK THE PATIENT IN THE NEAR FUTURE, BUT IT IS UNKNOWN AT THIS TIME WHEN. THE DEVICE WAS DISCARDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R