BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSION ANASTOMOSIS RING (CAR 27)

    MDR report key: 2078128 · Received April 8, 2011

    Report

    Report Number
    3005278776-2011-00021
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 9, 2011
    Manufacturer
    NITI SURGICAL SOLUTIONS LTD.
    Product Code
    FZP
    PMA / PMN Number
    K062008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON BEHALF OF THE MFR (NITI SURGICAL SOLUTIONS LTD; (B)(4)) AND THE IMPORTER (B)(4), AS NITI SURGICAL SOLUTIONS LTD. SERVES AS THE DESIGNATED COMPLAINT HANDLING UNIT FOR BOTH FACILITIES. IT SHOULD BE NOTED THAT THIS IS THE FIRST TIME THAT AN ALLEGED MALFUNCTION OF THIS TYPE (RELATED TO THE COMPRESSION ELEMENT THAT COULD NOT BE RELEASED AND THUS THE APPLICATOR COULD NOT BE TAKEN OUT) HAS BEEN REPORTED TO THE COMPANY. THE DEVICE WAS NOT AVAILABLE FOR EVAL, HOWEVER, THE PRODUCTION HISTORY FILES INDICATED THAT THE DEVICE WAS RELEASED PURSUANT TO THE PRODUCT SPECIFICATIONS. BASED ON DEVICE'S PHOTOGRAPHS, WHICH WERE REC'D ALONG WITH THE COMPLAINT REPORTING FORMS, IT IS QUITE OBVIOUS THAT THE PLASTIC ANVIL WAS NOT SEVERED BY THE BLADE. IT THEREFORE SEEMS THAT THE USER PRESSED THE CUTTING LEVER ONLY PARTIALLY AND THE BLADE DID NOT SEVER THE PLASTIC ANVIL AND THEREFORE THE COMPRESSION ELEMENT COULD NOT BE RELEASED FROM THE APPLICATOR. IT WAS THEREFORE CONCLUDED THAT THE EVENT WAS MOST PROBABLY NOT RELATED TO A FAILURE IN THE DEVICE BUT RATHER TO A USER'S ERROR AS THE DEVICE WAS NOT OPERATED ACCORDING TO THE INSTRUCTIONS IN THE IFU. THE RED MARKER WAS RELEASED DURING THE ATTEMPTS TO REMOVE THE DEVICE. THIS MARKER ONLY SERVES AS AN ADD'L INDICATION OF THE SEQUENTIAL STATUS OF DEVICE OPERATION AND HAS NO IMPACT UPON DEVICE SAFETY OR THE OUTCOME OF THE PROCEDURE.

    Description of Event or Problem · 1

    A PT UNDERWENT A LAPAROSCOPIC SIGMOIDECTOMY PROCEDURE DUE TO A COLONIC CANCER. WHEN THE SURGEON'S ASSISTANT TURNED THE OPERATION KNOB AND TRIED TO FIRE THE APPLIER, THE DEVICE WAS FIRED BUT THE OPERATOR COULDN'T TAKE THE APPLICATOR OUT. DURING THE ATTEMPTS TO RELEASE THE APPLICATOR THE RED INDICATOR DROPPED DOWN. THE ANASTOMOSIS WAS REDONE USING A STAPLER.

    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 43271212

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention