BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH STEALTH CIR STAPLER

    MDR report key: 1993533 · Received February 16, 2011

    Report

    Report Number
    3005075853-2011-00653
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Report Date
    February 2, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    KOG
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION: THE SURGEON IS TRIMMING THE ANCILLARY TROCAR WITH A KNIFE IN ORDER TO REMOVE IT EASIER. THE REP HAS BEEN INFORMED THAT THIS IS AGAINST THE INSTRUCTIONS IN THE IFU FOR THE USE OF THE DEVICE AND SHE HAS CONFIRMED THAT THE SURGEON WAS MADE AWARE OF IT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC ROUX-EN-Y PROCEDURE, THE SURGEON'S TECHNIQUE IS TO CREATE AN OTOMY WITH HARMONIC, PUT THE ANVIL IN THE STOMACH, PUSH IT THROUGH THE STOMACH AND THEN SUTURE UP THE OTOMY. WHEN REMOVING THE ANCILLARY BLUE TROCAR PRIOR TO PUTTING THE ANVIL ONTO THE CIRCULAR STAPLER, THE SURGEON EXPRESSED A CONCERN WITH THE PATIENT'S SAFETY DUE TO THE DIFFICULTY IN GETTING THE ANCILLARY BLUE TROCAR PIECE IN AND OUT OF THE ANVIL SO THAT THE CIRCULAR STAPLER CAN BE FIRED. PROCEDURE WAS COMPLETED AS NORMAL. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE WAS DISCARDED.

    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