BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESSION ANASTOMOSIS RING

    MDR report key: 2853176 · Received July 29, 2008

    Report

    Report Number
    3005278776-2008-00004
    Event Type
    Injury
    Date Received
    July 29, 2008
    Date of Event
    June 11, 2008
    Report Date
    July 29, 2008
    Manufacturer
    NITI SURGICAL SOLUTINS LTD.
    Product Code
    FZP
    PMA / PMN Number
    K062008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO CORRECTIVE ACTION OR REMEDIAL ACTIONS. MINOR LEAKS ARE COMMON ADVERSE EVENTS IN THIS KIND OF PROCEDURE.

    Description of Event or Problem · 1

    ANASTOMOTIC LEAK-PATIENT PRESENTED WITH A FEVER OF 103 DEGREES P.O.D. 4. THE PATIENT TESTED POSITIVE FOR AIR IN ABDOMEN ON P.O.D. 5 AND WAS RE-OPERATED ON. THE ANASTOMOSIS WAS SHOWN TO HAVE AN APPROXIMATELY 2MM LEAK ON THE RIGHT LATERAL POSTERIOR SIDE OF THE CAR 27 RING. DR (B)(6) USED SEVEN 2-0 VICRYL SUTURES TO REPAIR THE DEFECT. AN AIR BUBBLE TEST WAS PERFORMED AND TESTED NEGATIVE. A DIVERTING LOOP ILEOSTOMY WAS PERFORMED. DR (B)(6) WILL SCOPE THE PATIENT EVERY 2 DAYS POST OPERATIVE TO FOLLOW THE PROGRESSION OF THE HEALING OF THE ANASTOMOSIS. COLONOSCOPY (B)(6) 2008 P.O.D. 12.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPRESSION ANASTOMOSIS RING CAR 27 FZP NITI SURGICAL SOLUTINS LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization