BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFTEY LOCK-OUT

    MDR report key: 2031616 · Received March 28, 2011

    Report

    Report Number
    3005075853-2011-01216
    Event Type
    Injury
    Date Received
    March 28, 2011
    Report Date
    March 3, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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

    ADDITIONAL INFORMATION WAS REQUESTED ON (B)(6) 2011, (B)(6) 2011 AND (B)(6) 2011 AND NO ADDITIONAL INFORMATION WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST-OPERATIVE OF AN UNKNOWN PROCEDURE, PATIENT RETURNED FOR LEAKAGE OF THE STAPLE LINE. NO OTHER DETAILS OF THE EVENT ARE PRESENTLY KNOWN. DEVICE WAS DISCARDED. ADDITIONAL INFORMATION WAS REQUESTED, BUT TO DATE NO MORE INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFTEY LOCK-OUT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other RELOAD = (B)(4)