BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSNARE POLYPECTOMY SNARE

    MDR report key: 10487601 · Received September 3, 2020

    Report

    Report Number
    1037905-2020-00355
    Event Type
    Malfunction
    Date Received
    September 3, 2020
    Date of Event
    August 7, 2020
    Report Date
    September 3, 2020
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    FDI
    UDI-DI
    00827002226470
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONTINUED FROM PMA/510K: K191048. INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED COULD NOT CONFIRM THE REPORT AS DESCRIBED. DURING A VISUAL EVALUATION, THERE IS A KINK ON THE CATHETER AT 5 TO 5.5 CM FROM THE DISTAL END OF THE HANDLE. DURING A FUNCTION TEST, THE HANDLE OF THE DEVICE WAS MANIPULATED, AND THE SNARE HEAD WOULD ADVANCE AND RETRACT AS INTENDED. THE CONTINUITY FROM THE ELECTRICAL PIN TO THE SNARE HEAD WAS TESTED WITH AN OHM METER AND PASSED. AN ADDITIONAL FUNCTIONAL TEST WAS PERFORMED BY ATTACHING THE ACTIVE CORD TO THE ELECTRICAL PIN. THE ACTIVE CORD CONNECTED TO THE DEVICE EASILY AND REMAINED SECURELY CONNECTED. THE DEVICE WAS CONNECTED TO A VALLEY LAB GENERATOR AND POWER WAS APPLIED. THE SNARE CUT SIMULATED TISSUE AS EXPECTED. A LAB MEETING WAS HELD WITH MANUFACTURING AND ENGINEERING, NO ANOMALIES WERE DETECTED WITH THE DEVICE CONSTRUCTION. 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 CONCLUSION: 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. THE INSTRUCTIONS FOR USE DIRECT THE USER TO: "FULLY RETRACT AND EXTEND SNARE TO CONFIRM SMOOTH OPERATION OF DEVICE." DAMAGE TO THE PRODUCT CAN OCCUR IF THE DEVICE EXPERIENCES EXCESSIVE PRESSURE DURING USE. PRIOR TO DISTRIBUTION, ALL ACUSNARE POLYPECTOMY SNARES ARE SUBJECTED TO A VISUAL INSPECTION. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED AND THIS REPRESENTS AN ISOLATED OCCURRENCE. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. 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 A COLONOSCOPY, THE PHYSICIAN USED AN ACUSNARE POLYPECTOMY SNARE. WHEN ATTEMPTING TO REMOVE THE POLYP USING THE SNARE, IT WAS DIFFICULT TO OPEN AND ALMOST IMPOSSIBLE TO CLOSE. IT WAS REALIZED THAT THERE WAS A KINK IN THE WIRE IN THE HANDLE OF THE SNARE. 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
    954945 ACUSNARE POLYPECTOMY SNARE FDI, SNARE, FLEXIBLE FDI COOK ENDOSCOPY G22647 W4347628 00827002226470

    Patients

    Seq Age Sex Outcome Treatment
    1