BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETS - ENDOSCOPIC LINEAR

    MDR report key: 2250582 · Received September 16, 2011

    Report

    Report Number
    3005075853-2011-03821
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    June 29, 2011
    Report Date
    August 24, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. DEVICE NOT RETURNED THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THE BATCHES INCLUDED IN THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A NEPHRECTOMY PROCEDURE, THE DEVICE WOULD CUT BUT STAPLED PARTIALLY. DURING THE USE OF THE INITIAL CARTRIDGE, THE DEVICE CUT BUT PARTIALLY STAPLED. THERE WAS A HEMORRHAGE AT THE MIDDLE OF THE STAPLES LINE. THE SURGEON HAS HAD DIFFICULTIES TO REMOVE THE DEVICE FROM THE TISSUES. THE PATIENT RECEIVED A BLOOD TRANSFUSION (NO INDICATION ON THE QUANTITY OF BLOOD) AND THE SURGEON CONVERTED IN LAPAROTOMY TO PERFORM HIS PROCEDURE WITHOUT FURTHER ISSUE. AT THIS DAY, THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS - ENDOSCOPIC LINEAR STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK H43D1V

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention