BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSNARE POLYPECTOMY SNARE

    MDR report key: 15915332 · Received December 5, 2022

    Report

    Report Number
    1037905-2022-00653
    Event Type
    Malfunction
    Date Received
    December 5, 2022
    Date of Event
    November 4, 2022
    Report Date
    December 5, 2022
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    FDI
    UDI-DI
    00827002226494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION REGARDING ALL MANUFACTURERS SECTION. PMA/510(K): K191048. INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN AN OPEN POUCH FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABEL MATCHES THE PRODUCT RETURNED. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. THE DEVICE WAS RETURNED WITH THE SNARE HEAD PARTIALLY ADVANCED. THE SNARE HEAD WAS DEFORMED/MISSHAPEN WHEN ADVANCED. THE SNARE WOULD NOT FULLY RETRACT INTO THE TUBING DUE TO THE MISSHAPEN/DEFORMITY. NO OTHER ANOMALIES WERE DETECTED WITH THE DEVICE. 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: OUR LABORATORY EVALUATION OF THE RETURNED DEVICE CONFIRMED THE REPORT FOR "BENT SNARE". A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED BECAUSE THE ACTUAL PRIOR TO USE CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. 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 DIRECT THE USER TO: "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 · 0

    IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK ACUSNARE POLYPECTOMY SNARE. IT WAS REPORTED [THAT THE] ACUSNARE WAS BENT WHEN REMOVED FROM PACKAGE. [SNARE] WAS NOT USED. OPENED A NEW SNARE OF THE SAME TYPE TO FINISH PROCEDURE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON 11/09/2022. DURING THE EVALUATION IT WAS NOTED THAT THE SNARE WAS DEFORMED AND PARTIALLY ADVANCED. THE SNARE WOULD NOT FULLY RETRACT DUE TO THE DEFORMITY. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1358268 ACUSNARE POLYPECTOMY SNARE FDI, SNARE, FLEXIBLE FDI WILSON-COOK MEDICAL INC G22649 W4611888 00827002226494

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown