BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSNARE POLYPECTOMY SNARE SOFT

    MDR report key: 23696627 · Received December 2, 2025

    Report

    Report Number
    1037905-2025-00810
    Event Type
    Malfunction
    Date Received
    December 2, 2025
    Date of Event
    November 4, 2025
    Report Date
    December 2, 2025
    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
    UT, 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 RETURNED IN THE COILED POSITION AND THE SHEATH WAS KINKED/BUCKLED. THIS IS MOST LIKELY DUE TO EXCESSIVE FORCE USED WHILE ATTEMPTING TO SNARE THE POLYP AND THAT THE DEVICE WAS USED WITHOUT AN ELECTROSURGICAL UNIT. THE DEVICE WAS RETURNED WITH THE SNARE RETRACTED INTO THE SHEATH. THERE WAS A REDDISH-BROWN SUBSTANCE THROUGHOUT THE LENGTH OF THE CATHETER. THE DEVICE WOULD ADVANCE AND RETRACT WHEN THE HANDLE WAS MANIPULATED, WITH SOME RESISTANCE DUE TO THE SHEATH BEING KINKED/BUCKLED AT THE BASE OF THE HANDLE. THE CONTINUITY FROM THE ELECTRICAL PINS 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 AND COAGULATED SIMULATED TISSUE WITH RESISTANCE. 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: 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: "THIS DEVICE IS USED ENDOSCOPICALLY IN THE REMOVAL AND CAUTERIZATION OF SESSILE POLYPS AND PEDUNCULATED POLYPS FROM WITHIN THE GASTROINTESTINAL TRACT... DO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN THE STATED INTENDED USE." THIS IS THE MOST LIKELY CAUSE OF THE REPORT. PERFORMING A COLD POLYPECTOMY CAN LEAD TO THE SHEATH BEING KINKED/BUCKLED AS EXCESSIVE FORCE MAY HAVE TO BE USED TO SNARE THE POLYP. 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 RARE. 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.

    Description of Event or Problem · 0

    DURING A DIAGNOSTIC COLONOSCOPY, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE SOFT. IT WAS REPORTED [THAT] THE [SNARE] DID NOT QUITE CUT WHEN THEY WERE TRYING TO GET THE POLYP. AT THE TIP BY THE HAND PIECE, THE SHEATH COILED UP. THE SNARE WAS USED COLD. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. 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
    1958568 ACUSNARE POLYPECTOMY SNARE SOFT ENDOSCOPIC ELECTROSURGICAL UNIT AND ACCESSORIES FDI WILSON-COOK MEDICAL INC (COOK ENDOSCOPY) G22703 W4973874 00827002227033

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown OLYMPUS 190