BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSNARE POLYPECTOMY SNARE

    MDR report key: 10678967 · Received October 14, 2020

    Report

    Report Number
    1037905-2020-00434
    Event Type
    Malfunction
    Date Received
    October 14, 2020
    Date of Event
    September 21, 2020
    Report Date
    October 14, 2020
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    FDI
    UDI-DI
    00827002226494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER OCCUPATION: COMPANY REPRESENTATIVE. PMA/510K: K191048. INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. DURING A VISUAL EVALUATION OF THE RETURNED DEVICE, THE SNARE HEAD WAS RETRACTED. HOWEVER, SINCE THERE IS A SEVERE BEND ON THE DISTAL END OF THE SNARE HEAD, IT WOULD NOT FULLY RETRACT AND A PORTION IS STICKING OUT OF THE CATHETER. AT THE DISTAL END OF THE HANDLE, THE CATHETER IS COLLAPSING DUE TO THE FORCE OF RETRACTING THE SNARE HEAD. DURING A FUNCTION TEST, THE HANDLE OF THE DEVICE WAS MANIPULATED, THE SNARE HEAD WOULD ADVANCE BUT NOT RETRACT AS INTENDED. THE SNARE HEAD IS SEVERELY BENT, AND THE TIP OF THE SNARE, THE DUCK BILL, IS POINTING INWARD. 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. 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 AN ENDOSCOPIC PROCEDURE TO REMOVE A POLYP, THE PHYSICIAN USED AN ACUSNARE POLYPECTOMY SNARE. THE DEVICE WAS OPENED AND PLACED DOWN THE ENDOSCOPE. WHEN THE USER OPENED UP THE SNARE, THE USER NOTED THAT THE TIP WAS BENT AND SUBSEQUENTLY THE SNARE WOULD NOT FULLY RETRACT [SUBJECT OF REPORT]. THE USER REMOVED THE ENTIRE DEVICE AND SET IT ASIDE. 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
    1141963 ACUSNARE POLYPECTOMY SNARE FDI, SNARE, FLEXIBLE FDI COOK ENDOSCOPY G22649 W4302523 00827002226494

    Patients

    Seq Age Sex Outcome Treatment
    1