BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 45 ENDOPATH

    MDR report key: 3220963 · Received July 11, 2013

    Report

    Report Number
    3005075853-2013-03514
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, BUT NO FURTHER DETAILS COULD BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4): DEVICE NOT RETURNED. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. AS A LOT NUMBER WAS NOT RECEIVED, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE BECAME STUCK ON BROCHUS TISSUE AND THEY WERE UNABLE TO GET DEVICE TO RELEASE. AN ALTERNATE METHOD TO RELEASE THE INSTRUMENT WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320286 ECHELON 45 ENDOPATH STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1