BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILS 29MM, CURVED

    MDR report key: 3240527 · Received July 22, 2013

    Report

    Report Number
    3005075853-2013-03664
    Event Type
    Injury
    Date Received
    July 22, 2013
    Report Date
    June 26, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO HAVE DEVICE RETURNED. DEVICE LOCATION IS UNKNOWN. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A LAPAROSCOPIC SIGMOID PROCEDURE THE ANASTOMOSE GOT A LEAKAGE ON SECOND DAY. DURING OPERATION ANASTOMOSIS WAS COMPLETE AND THE TEST WAS OK. ON THE SECOND DAY THERE WAS REOPERATION. THEY COULD STOP THE BLEEDING WITH A CLIP. NO FURTHER INFORMATION IS AVAILABLE. THERE WERE NO OTHER REPORTED PATIENT CONSEQUENCES ADDITIONAL INFORMATION HAS BEEN REQUESTED, NO RESPONSE HAS BEEN RECEIVED TO DATE, A SUPPLEMENTAL REPORT WILL BE SENT UPON RECEIPT OF ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341389 ILS 29MM, CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK K4C65G

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention