BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH STEALTH CIR STAPLER

    MDR report key: 2163006 · Received July 15, 2011

    Report

    Report Number
    3005075853-2011-02895
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 16, 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
    TX, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS BEING USED IN A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE. THE NURSE ASKED HOW TO GET THE BLUE POST OUT OF THE ANVIL AS PART OF THE BLUE POST HAS BROKEN OFF. THE DEVICE WAS INSIDE THE PATIENT. INSTRUCTED TO GRASP THE ANCILLARY TROCAR AND PULL OUTWARDS. NURSE AND PHYSICIAN STATED THAT BLUE ANCILLARY TROCAR WOULD NOT COME OUT AFTER 25 MINUTES OF TRYING. NO OTHER INFORMATION AVAILABLE AT THIS TIME. ATTEMPTS WERE COMPLETED IN ORDER TO OBTAIN MORE INFORMATION AND NO RESPONSE WAS RECEIVED.

    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