BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSNARE POLYPECTOMY SNARE

    MDR report key: 10725955 · Received October 23, 2020

    Report

    Report Number
    1037905-2020-00458
    Event Type
    Malfunction
    Date Received
    October 23, 2020
    Report Date
    October 23, 2020
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    FDI
    UDI-DI
    00827002226470
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510K: K191048. INVESTIGATION EVALUATION: THE DEVICE HISTORY RECORD WAS REVIEWED. THE DEVICE HISTORY RECORD CONTAINS A NONCONFORMANCE THAT COULD BE RELATED TO SNARE HEAD WILL NOT RETRACT. 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: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. THE INSTRUCTIONS FOR USE CONTAINS THE FOLLOWING INFORMATION TO ASSIST WITH PROPER SET-UP AND USE OF THE DEVICE: "FULLY RETRACT AND EXTEND SNARE TO CONFIRM SMOOTH OPERATION OF DEVICE. NOTE: IF USING AN ACUSNARE, SLIDE ADJUSTABLE MARKER, LOCATED IN HANDLE, TO ESTABLISH A REFERENCE POINT INDICATING FULL RETRACTION OF SNARE INTO SHEATH AND TO SET UP REFERENCE POINTS FOR ESTABLISHING THICKNESS OF TISSUE BEING EXCISED." 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: 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, THE PHYSICIAN USED TWO (2) ACUSNARE POLYPECTOMY SNARES. THE SNARE WOULD NOT OPEN AND CLOSE. CLARIFICATION WAS RECEIVED ON 15-SEPTEMBER-2020 WHICH STATES THAT THE SNARE WOULD ADVANCE, BUT WAS VERY DIFFICULT TO ADVANCE. THE CATHETER SEEM KINKED. THE SNARE WAS VERY DIFFICULT TO RETRACT. OUR ATTEMPTS TO COLLECT ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME WERE UNSUCCESSFUL. WHILE THE COMPLAINANT DID NOT SPECIFY IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS OR REQUIRED ADDITIONAL MEDICAL PROCEDURES DUE TO THIS EVENT, THE INFORMATION ABLE TO BE COLLECTED DOES NOT REASONABLY SUGGEST THE PATIENT WAS ADVERSELY IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1192661 ACUSNARE POLYPECTOMY SNARE FDI, SNARE, FLEXIBLE FDI COOK ENDOSCOPY G22647 W4354297 00827002226470

    Patients

    Seq Age Sex Outcome Treatment
    1