BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLONRING/COMPRESSION ANASTOMOSIS RING

    MDR report key: 3131084 · Received May 22, 2013

    Report

    Report Number
    3005278776-2013-00015
    Event Type
    Injury
    Date Received
    May 22, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 23, 2013
    Manufacturer
    NOVOGI
    Product Code
    FZP
    PMA / PMN Number
    K093661
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT IS SUBMITTED ON BEHALF OF THE MFR ((B)(4).) AND THE IMPORTER (B)(4), AS (B)(4). SERVES AS THE DESIGNATED COMPLAINTS HANDLING UNIT FOR BOTH FACILITIES. THE DEVICE WAS NOT RETURNED FOR EVAL AND NO FURTHER INFO IS CURRENTLY AVAILABLE THEREFORE, NO CONCLUSIONS COULD BE MADE. THE DEVICE'S IFU INCLUDES A RECOMMENDATION TO USE STOOL SOFTENERS TO AVOID SOLID STOOLS WHICH MAY EXERT UNDESIRABLE MECHANICAL FORCE ON THE ANASTOMOTIC AREA. ANASTOMOTIC LEAKAGE IS ONE OF THE MOST COMMON COMPLICATIONS OF COLORECTAL SURGERIES. THE CURRENT CUMULATIVE LEAK RATE FOUND WITH THE USE OF THE COLONRING IS WITHIN THE LOW RANGE REPORTED IN THE LITERATURE FOR ANASTOMOTIC DEVICES.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, THE PT UNDERWENT A SIGMOID RESECTION WITH SUS-DOUGLASSIENNE COLORECTAL ANASTOMOSIS DUE TO DIVERTICULITIS. THE PRESENTED ON POD 3 WITH PAIN AND FEVER ASSOCIATED WITH A PROBABLE ANASTOMOTIC FISTULA WITHOUT PERITONITIS. THE SURGEON INFERS THAT WITH SUCH PT BEING REPORTED AND RAPIDLY GOING BACK TO EAT AT POD 1 WITHOUT STOMA, SOLID STOOL CAME TO THE ANASTOMOSIS AREA AT POD 3 WITH GAS PRESSURE AND CAUSED A LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227728 COLONRING/COMPRESSION ANASTOMOSIS RING IMPLANTABLE CLIP (FZP) FZP NOVOGI COLONRING (CAR27)

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention