BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSNARE POLYPECTOMY SNARE SOFT

    MDR report key: 23866427 · Received December 22, 2025

    Report

    Report Number
    1037905-2025-00856
    Event Type
    Malfunction
    Date Received
    December 22, 2025
    Report Date
    January 16, 2026
    Manufacturer
    WILSON-COOK MEDICAL INC (COOK ENDOSCOPY)
    Product Code
    FDI
    UDI-DI
    00827002227033
    PMA / PMN Number
    K173673
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 IN THE COILED POSITION WITH NO SIGN OF DAMAGE TO THE SHEATH OR SNARE HEAD. WHEN THE HANDLE WAS ACTUATED, THE SNARE HEAD WOULD NOT ADVANCE AND THUS COULD NOT RETRACT. UPON FURTHER INVESTIGATION, IT WAS NOTED THAT THE HANDLE CANNULA WAS DISCONNECTED INSIDE OF THE HANDLE CAUSING THE DEVICE TO NOT MOVE. DUE TO THE CONDITION OF THE DEVICE, A FUNCTION TEST WAS NOT ABLE TO BE COMPLETED. THE DEVICE WAS RETURNED TO THE SUPPLIER FOR FURTHER EVALUATION AND THE FOLLOWING WAS PROVIDED, "THROUGH VISUAL EVALUATION IT COULD BE CONFIRMED THAT THE BRASS SNAP PIN WAS NOT PROPERLY POSITIONED. THE PUSHROD APPEARED TO BE BENT. EVALUATING THE CRIMP, IT CAN BE SEEN THAT THE CRIMP WAS NOT FULLY FORMED. THE SNARE HEAD REMAINED INTACT, AND ALL COMPONENTS OF THE DEVICE WERE IDENTIFIED AS PRESENT. FUNCTIONAL EVALUATION WAS NOT POSSIBLE TO BE PERFORMED DUE TO THE CONDITION OF THE RETURNED DEVICE. BASED ON THE VISUAL AND FUNCTIONAL EVALUATION OF THE DEVICE, THE REPORTED COMPLAINT THAT THE HANDLE WAS DISCONNECTED CAN BE CONFIRMED. THE CRIMP WAS NOT FULLY FORMED AND WAS NOT IDENTIFIED DURING ASSEMBLY PER ACUSNARE DEVICE ASSEMBLY DOCUMENTATION. THE PROCEDURE INSTRUCTS OPERATORS TO VERIFY THE CRIMP BY UTILIZING A RING GAUGE. THE UNSWAGED SECTION MUST FIT INSIDE THE GAUGE TO ENSURE THE PUSHROD IS NOT TOO LARGE OR MISSHAPED. THE SWAGED SECTION MUST NOT FIT THROUGH THE RING GAUGE, DURING THIS EVALUATION THE SWAGED SECTION FAILED TO MEET THESE CRITERIA. LASTLY, A TUG TEST IS PERFORMED TO ENSURE THE SNAP PIN CAN WITHSTAND MINOR APPLIED FORCE WITHOUT SHIFTING IN POSITION." THE DEVICE HISTORY RECORD WAS REVIEWED AND WAS MANUFACTURED AUGUST 2025. THERE WERE NO RELEVANT DEFECTS NOTED IN THE MANUFACTURING/FQC CHECKLISTS. 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 EVALUATION OF THE RETURNED DEVICE CONFIRMED THE REPORT. THE SUPPLIER PROVIDED THE FOLLOWING, "ROOT CAUSE WAS DETERMINED TO BE HUMAN ERROR. THE CRIMP WAS NOT SUFFICIENT WHICH LED TO THE BRASS SNAP PIN NOT MAINTAINING CONNECTION WITH THE PUSHROD. AWARENESS TRAINING ON THIS RMA AND PROCEDURE ACUSNARE DEVICE ASSEMBLY WILL BE PERFORMED WITH THE OPERATORS. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO ANOMALIES WERE NOTED. THE VISUAL EVALUATION OF THE DEVICE CONFIRMED THE CUSTOMERS COMPLAINT OF A DISCONNECT IN THE HANDLE DUE TO AN INSUFFICIENT CRIMP." THE ADDITIONAL INFORMATION PROVIDED BY THE USER STATED THAT A COLD POLYPECTOMY WAS PERFORMED. THIS IS AGAINST THE INTENDED USE OF THE DEVICE. THE INSTRUCTIONS FOR USE STATE: "THE POLYPECTOMY DEVICES ARE USED BY TRAINED PROFESSIONALS IN CONJUNCTION WITH A COMPATIBLE ENDOSCOPE AND ELECTROSURGICAL UNIT FOR RESECTION OF SESSILE AND/OR PEDUNCULATED POLYPS IN THE GASTROINTESTINAL TRACT... DO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN THE STATED INTENDED USE." 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: BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS REMOTE. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS. ADDITIONAL COMMENTS: BASED ON THE INFORMATION PROVIDED THAT A COLD POLYPECTOMY WAS PERFORMED, A COOK REPRESENTATIVE HAS BEEN DIRECTED TO CONTACT THE MEDICAL FACILITY INVOLVED IN AN EFFORT TO PROMOTE FURTHER EDUCATION AND UNDERSTANDING RELATED TO APPROPRIATE USAGE OF THIS PRODUCT.

    Additional Manufacturer Narrative · 0

    THIS INVESTIGATION IS ON-GOING. A FOLLOW-UP EMDR WILL BE PROVIDED WITHIN 30 DAYS OF RECEIPT OF NEW INFORMATION.

    Description of Event or Problem · 0

    DURING AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE SOFT. THE DEVICE WAS RECEIVED ON 01DEC2025 AND IT WAS DETERMINED THAT THE SNARE HEAD CANNOT BE ADVANCED DUE TO A DISCONNECTION IN THE HANDLE [SUBJECT OF REPORT]. ON 04DEC2025, IT WAS REPORTED BY THE CUSTOMER THAT THE SNARE WAS USED COLD [AGAINST IFU] AND WOULD CUT BUT NOT EXTEND. 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
    1745307 ACUSNARE POLYPECTOMY SNARE SOFT ENDOSCOPIC ELECTROSURGICAL UNIT AND ACCESSORIES FDI WILSON-COOK MEDICAL INC (COOK ENDOSCOPY) G22703 W4973843 00827002227033

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown OLYMPUS ENDOSCOPE, UNKNOWN MODEL