BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO ILS, 29MM, CURVED

    MDR report key: 2011858 · Received March 9, 2011

    Report

    Report Number
    3005075853-2011-00938
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 14, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 DURING AN UNKNOWN PROCEDURE, THE SURGEON WAS TRYING TO CREATE AN ANASTOMOSIS AND COULD NOT GET THE ANVIL TO ATTACH TO THE TROCAR. HE THEN USED ANOTHER DEVICE WITH THE SAME TROCAR AND COMPLETED THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO ILS, 29MM, CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1