BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESSION ANASTOMOSIS RING CAR 27/COLONRING

    MDR report key: 1817127 · Received August 23, 2010

    Report

    Report Number
    3005278776-2010-00122
    Event Type
    Injury
    Date Received
    August 23, 2010
    Date of Event
    May 9, 2010
    Report Date
    July 23, 2010
    Manufacturer
    NITI SURGICAL SOLUTIONS LTD.
    Product Code
    FZP
    PMA / PMN Number
    K062008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON BEHALF OF THE MANUFACTURER (NITI SURGICAL SOLUTIONS LTD; 3005278776) AND THE (B)(4), AS NITI SURGICAL SOLUTIONS LTD SERVES AS THE DESIGNATED COMPLAINT HANDLING UNIT FOR BOTH FACILITIES. THE RING WAS NOT RETURNED FOR EVAL, HOWEVER, THE PRODUCTION HISTORY FILE WAS REVIEWED, INDICATING THAT THE DEVICE WAS RELEASED ACCORDING TO THE PRODUCT SPECIFICATIONS. LEAKS ARE ANTICIPATED ADVERSE EVENTS IN COLORECTAL ANASTOMOTIC PROCEDURES AND THE CURRENT CUMULATIVE LEAK RATE REPORTED IN THE LITERATURE FOR ANASTAMOSIS DEVICES.

    Description of Event or Problem · 1

    THE PT UNDERWENT DA VINCI ASSISTED LOW ANTERIOR RESECTION SURGERY DUE TO RECTAL CANCER. END TO END ANASTOMOSIS WAS PERFORMED WITH THE CAR. THE PT RECOVERED WELL WITHOUT ANY PROBLEM UNTIL POD #6. FEVER WAS DEVELOPED IN POD #7 WITH NO ABDOMINAL PAIN. ABDOMINAL CT WAS TAKEN ON POD #8. THE RESULT OF THE CT DIDN'T SHOW CLEARLY WHETHER THERE IS AN ANASTOMOTIC LEAK. THE SURGEON DECIDED TO TAKE PRECAUTION STEPS. HE PERFORMED EXPLORATIVE LAPAROSCOPY, IRRIGATED AND DRAINED THE ABDOMEN VIA THE LAPAROSCOPE, AND DIVERTED THE PT. NO FURTHER STEPS WERE TAKEN AND THE PT RECOVERED WITHOUT ANY FURTHER EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPRESSION ANASTOMOSIS RING CAR 27/COLONRING IMPLANTABLE CLIP (FZP) FZP NITI SURGICAL SOLUTIONS LTD. CAR 27/COLONRING 43271209

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention