BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESSION ANASTOMOSIS RING (CAR 27)

    MDR report key: 1910583 · Received November 19, 2010

    Report

    Report Number
    3005278776-2010-00146
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 21, 2010
    Manufacturer
    NITI SURGICAL SOLUTIONS LTD.
    Product Code
    FZP
    PMA / PMN Number
    K062008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON BEHALF OF THE MANUFACTURER (NITI SURGICAL SOLUTIONS LTD; 3005278776) AND THE IMPORTER (B)(4), AS NITI SURGICAL SOLUTIONS LTD. SERVES AS THE DESIGNATED COMPLAINT HANDLING UNIT FOR BOTH FACILITIES. THE DEVICE WAS NOT RETURNED FOR EVALUATION, HOWEVER, THE PRODUCT HISTORY FILES WERE REVIEWED, INDICATING THAT THE DEVICE WAS RELEASED ACCORDING TO THE PRODUCT SPECIFICATIONS. THE CASE IS A LOW RECTAL ANASTOMOSIS THAT HAS BEEN DIVERTED. IN SUCH CASES, DUE TO LACK OF PERISTALTIC MOVEMENT, THE RING MAY NEED TO BE REMOVED DIGITALLY, AS DONE BY THE SURGEON IN THIS CASE. ANASTOMOTIC LEAKAGE, INCLUDING ABSCESSES, IS ONE OF THE MOST COMMON COMPLICATIONS OF COLORECTAL ANASTOMOTIC PROCEDURES WITH BOTH STAPLERS AND COMPRESSION ANASTOMOSIS DEVICES. THE CURRENT CUMULATIVE LEAK RATE FOLLOWING USE OF COLONRING DEVICE IS WITHIN THE LOW RANGE REPORTED IN THE LITERATURE FOR ANASTOMOSIS DEVICES. OBESITY, WHICH INDICATED IN THIS CASE, IS KNOWN TO BE ASSOCIATED WITH AN INCREASED RISK OF ANASTOMOTIC FAILURE.

    Description of Event or Problem · 1

    ANASTOMOSIS WITH THE COLONRING WAS CREATED IN A PATIENT WHO UNDERWENT LAPAROSCOPIC ANTERIOR RESECTION PROCEDURE (5 CM FROM THE ANAL VERGE) DUE TO RECTAL CANCER. ON POD 13, THE COLONRING WAS MANUALLY REMOVED BY THE SURGEON. ON POD 22 ((B)(6) 2010), THE SUBJECT EXPERIENCED BACK PAIN THAT WAS SUSPECTED AS RECTAL ABSCESS. ON (B)(6) 2010, IT WAS DETERMINED THAT THE PATIENT HAS INTRA-ABDOMINAL ABSCESS WITH RADIOLOGICALLY CONFIRMED LEAK. THE ABSCESS WAS TREATED WITH DRAINAGE AND ANTIBIOTIC (FLAGYL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPRESSION ANASTOMOSIS RING (CAR 27) IMPLANTABLE CLIP (FZP) FZP NITI SURGICAL SOLUTIONS LTD. CAR 27 (COLONRING) 43001004

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention FOSINOPRIL NATRIUM| AERIUS| CODEINEFOSFAAT