BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN AUTOSUTURE PRODUCT

    MDR report key: 2553216 · Received April 25, 2012

    Report

    Report Number
    1219930-2012-00356
    Event Type
    Death
    Date Received
    April 25, 2012
    Date of Event
    January 18, 2010
    Report Date
    March 29, 2012
    Manufacturer
    COVIDIEN LP, FORMERLY US SUR
    Product Code
    OCW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: NEPHRECTOMY. ACCORDING TO THE RPTR: ON (B)(6) 2010, THE PT UNDERWENT A LAPAROSCOPIC NEPHRECTOMY AND IT IS ALLEGED THAT THE STAPLER FAILED TO FIRE PROPERLY AND DID NOT PROVIDE PROPER VASCULAR CONTROL. THE LAPAROSCOPIC CASE WAS CONVERTED TO AN OPEN PROCEDURE. THE PT SUSTAINED A SIGNIFICANT VASCULAR INJURY WHICH RESULTED IN MASSIVE BLOOD LOSS AND SUBSEQUENT CARDIAC ARREST. ON (B)(6) 2010, THE PT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN AUTOSUTURE PRODUCT SURGICAL STAPLING DEVICE OCW COVIDIEN LP, FORMERLY US SUR

    Patients

    Seq Age Sex Outcome Treatment
    1 Death