BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTINCT ENDOSCOPIC HEMOCLIP

    MDR report key: 4093176 · Received August 21, 2014

    Report

    Report Number
    1037905-2014-00330
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Date of Event
    June 14, 2014
    Report Date
    July 24, 2014
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    FHN
    PMA / PMN Number
    K132809
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED COULD NOT CONFIRM THE REPORT AS IT WAS DESCRIBED, BECAUSE ALL THE DEVICE COMPONENTS (PARTICULARLY THE CLIP) WERE NOT INCLUDED IN THE RETURN, DUE TO BEING DEPLOYED INSIDE THE PATIENT. DURING A FUNCTIONAL TEST, THE DEVICE WAS ADVANCED INTO A PENTAX EC3830-TL COLONOSCOPE IN A SIMULATED LOWER GI POSITION WITH THE TIP IN THE MAXIMUM RETROFLEXED POSITION TO SIMULATE A WORST CASE POSITION. WITH HANDLE MANIPULATION, THE DRIVE WIRE MOVED FREELY INSIDE THE OUTER SHEATH. A VISUAL EXAMINATION OF THE DISTAL END DEVICE COMPONENTS SHOWED NO DEFORMITIES OR SIGNS OF DAMAGE. A PRODUCT DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS REPORTED OCCURRENCE WAS NOT OBSERVED. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSIONS: A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PATIENT ANATOMY, ENDOSCOPE POSITION OR PROGRESSION OF DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LABORATORY ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. PRIOR TO DISTRIBUTION, ALL INSTINCT ENDOSCOPIC HEMOCLIPS ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTIONS: CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, A COOK INSTINCT ENDOSCOPIC HEMOCLIP WAS USED. THE PHYSICIAN STATED ONCE THE DEVICE WAS ATTACHED TO SITE THE CLIP WOULD NOT RELEASE. THE CLIP EVENTUALLY WAS ABLE TO BE RELEASED FROM THE CATHETER, BUT ALMOST TORE THE ISSUE. THE PHYSICIAN THEN USED ANOTHER CLIP AND WAS ABLE TO COMPLETE THE ORIGINALLY INTENDED PROCEDURE WITH NO FURTHER COMPLICATIONS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506888 INSTINCT ENDOSCOPIC HEMOCLIP FHN WILSON-COOK MEDICAL INC W3406541

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS ENDOSCOPE (UNK MODEL NUMBER)