BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSNARE POLYPECTOMY SNARE

    MDR report key: 10935059 · Received December 2, 2020

    Report

    Report Number
    1037905-2020-00518
    Event Type
    Malfunction
    Date Received
    December 2, 2020
    Date of Event
    November 5, 2020
    Report Date
    December 2, 2020
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    FDI
    UDI-DI
    00827002226470
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER; OCCUPATION: OTHER HEALTHCARE PROFESSIONAL: TECH. PMA/510(K) # K191048. INVESTIGATION EVALUATION: THE DEVICE SAID TO BE INVOLVED WAS RETURNED IN AN OPEN POUCH FROM THE SAME LOT NUMBER PROVIDED IN THE REPORT. THE LABEL MATCHES THE PRODUCTS RETURNED. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED COULD NOT CONFIRM THE REPORT AS IT WAS DESCRIBED. THE HANDLE OF THE DEVICE WAS MANIPULATED AND THE SNARE HEAD WOULD OPEN AND CLOSE WITH NO RESISTANCE FELT. DURING A VISUAL INSPECTION OF THE DEVICE, THERE WAS NO DAMAGE NOTED ON THE DEVICE. THE CONTINUITY FROM THE ELECTRICAL PIN TO THE SNARE HEAD WAS TESTED WITH AN OHM METER AND PASSED. AN ADDITIONAL FUNCTIONAL TEST WITH THE DEVICE 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 PRODUCTION AND NO DEFECTS WERE FOUND AFTER A VISUAL AND FUNCTIONAL EVALUATION OF THE DEVICE. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. THE DEVICE HISTORY RECORD CONTAINS NONCONFORMANCES THAT COULD POTENTIALLY BE RELATED TO THIS REPORT. THE DEVICE GOES THROUGH DIFFERENT INSPECTIONS PRIOR TO LEAVING THE FACILITY. THESE INSPECTIONS WOULD HAVE REMOVED ANY NONCONFORMING DEVICES PRIOR TO DISTRIBUTION. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSION: A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED BECAUSE THE PRODUCT SAID TO BE INVOLVED FUNCTIONED AS INTENDED. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS OF THE RETURNED PRODUCT. THE INSTRUCTIONS FOR USE CONTAINS THE FOLLOWING INFORMATION TO ASSIST WITH PROPER SETUP AND USE OF THE DEVICE: "FULLY RETRACT AND EXTEND SNARE TO CONFIRM SMOOTH OPERATION OF DEVICE." PRIOR TO DISTRIBUTION, ALL ACUSNARE POLYPECTOMY SNARES 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 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 POLYPECTOMY, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE AND THERE WAS RESISTANCE IN OPENING AND CLOSING THE DEVICE [DIFFICULTY WITH RETRACTION SUBJECT OF REPORT]. A NEW DEVICE WAS OPENED AND USED TO COMPLETE THE INTENDED PROCEDURE SUCCESSFULLY." 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
    1399901 ACUSNARE POLYPECTOMY SNARE FDI, SNARE, FLEXIBLE FDI COOK ENDOSCOPY G22647 W4354297 00827002226470

    Patients

    Seq Age Sex Outcome Treatment
    1