BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)

    MDR report key: 2999893 · Received March 8, 2013

    Report

    Report Number
    3005278776-2013-00006
    Event Type
    Injury
    Date Received
    March 8, 2013
    Date of Event
    January 1, 2012
    Report Date
    February 8, 2013
    Manufacturer
    NOVOGI LTD.
    Product Code
    FZP
    PMA / PMN Number
    K093661
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON BEHALF OF THE MANUFACTURER (NOVOGI LTD) AND THE IMPORTER ((B)(4)), AS NOVOGI LTD. SERVES AS THE DESIGNED COMPLAINT HANDLING UNIT FOR BOTH FACILITIES. THE ONLY INFO THAT IS AVAILABLE IS THAT THERE WAS A MILD LEAK DETECTED DURING THE PNEUMATIC TEST. THIS INFO COULD NOT BE VERIFIED AND THE DEVICE AND/OR ITS IDENTIFICATION WERE NOT RECEIVED, DESPITE REPEATED ATTEMPTS TO RECEIVE ADDITIONAL INFO. THEREFORE, NO FURTHER INVESTIGATION COULD BE CONDUCTED AND NO CONCLUSIONS COULD BE DRAWN. CONTINUED ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFO REGARDING THIS CASE AND A SUPPLEMENTAL MDR WILL BE SUBMITTED IN THE EVENT ANY NEW INFO IS RECEIVED. IT SHOULD BE NOTED THAT A POSITIVE LEAK TEST DURING THE SURGICAL PROCEDURE IS AN ANTICIPATED EVENT WITH ANASTOMOTIC DEVICES AND MAY BE RELATED TO A FAILURE IN THE SURGICAL TECHNIQUE LEAKS DETECTED AT THIS STAGE ENABLE IMMEDIATE INTRAOPERATIVE REPAIR OR STRENGTHENING OF THE ANASTOMOTIC AREA.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON BEHALF OF THE MANUFACTURER (NOVOGI LTD) AND THE IMPORTER ((B)(4)), AS NOVOGI LTD. SERVES AS THE DESIGNED COMPLAINT HANDLING UNIT FOR BOTH FACILITIES. THE ONLY INFO THAT IS AVAILABLE IS THAT THERE WAS A MILD LEAK DETECTED DURING THE PNEUMATIC TEST. THIS INFO COULD NOT BE VERIFIED AND THE DEVICE AND/OR ITS IDENTIFICATION WERE NOT RECEIVED, DESPITE REPEATED ATTEMPTS TO RECEIVE ADDITIONAL INFO. THEREFORE, NO FURTHER INVESTIGATION COULD BE CONDUCTED AND NO CONCLUSIONS COULD BE DRAWN. CONTINUED ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFO REGARDING THIS CASE AND A SUPPLEMENTAL MDR WILL BE SUBMITTED IN THE EVENT ANY NEW INFO IS RECEIVED. IT SHOULD BE NOTED THAT A POSITIVE LEAK TEST DURING THE SURGICAL PROCEDURE IS AN ANTICIPATED EVENT WITH ANASTOMOTIC DEVICES AND MAY BE RELATED TO A FAILURE IN THE SURGICAL TECHNIQUE LEAKS DETECTED AT THIS STAGE ENABLE IMMEDIATE INTRAOPERATIVE REPAIR OR STRENGTHENING OF THE ANASTOMOTIC AREA.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED: "THERE WAS A MILD LEAK DETECTED DURING THE PROCEDURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99763 COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27) IMPLANTABLE CLIP (FZP) FZP NOVOGI LTD. COLONRING (CAR27)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention