BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA

    MDR report key: 7271261 · Received February 14, 2018

    Report

    Report Number
    2647580-2018-00727
    Event Type
    Injury
    Date Received
    February 14, 2018
    Date of Event
    December 29, 2017
    Report Date
    February 14, 2018
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    UDI-DI
    20884523005551
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE PATIENT UNDERWENT A LAPAROSCOPIC SIGMOIDECTOMY PROCEDURE. THE CIRCULAR STAPLER WAS BEING USED FOR THE ANASTOMOSIS OF THE COLON AT THE END OF THE PROCEDURE. THERE WAS AN ANASTOMOSIS INSUFFICIENCY WHICH LED TO BLEEDING POST OPERATIVELY. MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. CONSERVATIVE TREATMENTS DURING TWO DAYS POST OPERATIVELY, HB 130-115. THE BLOOD LOSS WAS LESS THAN 500 CC. THE PATIENT OUTCOME HAS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113219 EEA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO EEA31 P7J0950KX 20884523005551

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention