BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE ILS CURVED CIR STAPL

    MDR report key: 1934029 · Received December 21, 2010

    Report

    Report Number
    3005075853-2010-07305
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    December 8, 2010
    Report Date
    December 12, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. 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 THE DEVICE WAS USED DURING A RECTAL CARCINOMA AND RESECTION PROCEDURE ON (B)(6) 2010. DURING THE PROCEDURE, THE SURGEON USED THE DEVICE TO ANASTOMOSE THE TISSUE. AT NIGHT AFTER THE PROCEDURE, THE SURGEON FOUND THAT THE ANASTOMOSIS HAD OOZED BLOOD. SO ON (B)(6) 2010, THE PATIENT HAD A SECOND PROCEDURE AND THE SURGEON USED HAND SEWING TO REINFORCE THE ANASTOMOSIS. NO BLOOD TRANSFUSION. NOW THE PATIENT IS FINE. BECAUSE THE PATIENT HAD THE SECOND LIVER, THE SAMPLE WAS DISCARDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other| R