BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSNARE POLYPECTOMY SNARE SOFT

    MDR report key: 25094910 · Received May 6, 2026

    Report

    Report Number
    1037905-2026-00214
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Date of Event
    March 3, 2026
    Report Date
    May 6, 2026
    Manufacturer
    WILSON-COOK MEDICAL INC (COOK ENDOSCOPY)
    Product Code
    FDI
    UDI-DI
    00827002226326
    PMA / PMN Number
    K173673
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUED: E1: INITIAL REPORTER ESTABLISHMENT NAME: (B)(6). 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 SNARE HEAD WAS FRAYED. THE DEVICE RETURNED WITH THE SNARE RETRACTED INTO THE SHEATH. NO DAMAGE TO THE SHEATH OR HANDLE WAS NOTED. THE SNARE HEAD WAS ABLE TO ADVANCE AND RETRACT AS EXPECTED WHEN THE HANDLE WAS MANIPULATED. THE SNARE HEAD WAS CONFIRMED TO BE THE CORRECT COMPONENT. THERE IS A DARK/BURNT COLOR ON THE SNARES DISTAL TIP THAT APPEARS TO BE EVIDENCE OF CAUTERY. 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 ONLY MINIMALLY CUT AND COAGULATED SIMULATED TISSUE; IT TOOK SIGNIFICANT TIME AND REPETITIONS TO REMOVE SIMULATED TISSUE. 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 SNARE HEAD WAS FRAYED WHICH CAN INTERFERE WITH CUTTING ABILITY. A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PATIENT ANATOMY, ENDOSCOPE POSITION OR PROGRESSION OF DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LABORATORY ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. ONE POSSIBLE CAUSE OF THIS REPORT IS USE WITH AN INCOMPATIBLE ACTIVE CORD. THE IFU STATES "THIS DEVICE MUST ONLY BE USED WITH AN ACTIVE CORD COMPATIBLE WITH A 3 MM DIAMETER CONNECTOR. THIS DEVICE HAS ONLY BEEN VERIFIED TO BE COMPATIBLE WITH THE FOLLOWING COOK ACTIVE CORDS: ACU-1 AND ACU-1-VL (SUPPLIED NON-STERILE)." "DO NOT USE THIS DEVICE WITH AN ACTIVE CORD WHICH HAS A MAXIMUM VOLTAGE RATING LESS THAN 5KVP-P (2500 VP). THIS COULD CAUSE THERMAL INJURY TO THE PATIENT, OPERATOR, OR ASSISTANT." THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING ADDITIONAL INFORMATION TO ASSIST WITH PROPER SET-UP AND USE OF THE DEVICE: "BEFORE USING THIS DEVICE, FOLLOW THE RECOMMENDATIONS PROVIDED BY THE ELECTROSURGICAL UNIT MANUFACTURER TO ENSURE PATIENT SAFETY THROUGH THE PROPER PLACEMENT AND UTILIZATION OF THE PATIENT RETURN ELECTRODE. ENSURE THAT A PROPER PATH FROM THE PATIENT RETURN ELECTRODE TO THE ELECTROSURGICAL UNIT IS MAINTAINED THROUGHOUT THE PROCEDURE." "INSPECT THE ACTIVE CORD. THE CORD MUST BE FREE OF KINKS, BENDS, BREAKS AND EXPOSED WIRES TO ALLOW FOR THE ACCURATE TRANSFER OF CURRENT. IF AN ABNORMALITY IS NOTED, DO NOT USE THE ACTIVE CORD." "SECURELY CONNECT THE ACTIVE CORD TO THE DEVICE HANDLE AND ELECTROSURGICAL UNIT. THE ACTIVE CORD FITTINGS SHOULD FIT SNUGLY INTO BOTH THE DEVICE HANDLE AND ELECTROSURGICAL UNIT. FOLLOWING THE INSTRUCTIONS FROM THE ELECTROSURGICAL UNIT MANUFACTURER, POSITION THE PATIENT RETURN ELECTRODE AND CONNECT IT TO THE ELECTROSURGICAL UNIT." "FOLLOWING ELECTROSURGICAL UNIT MANUFACTURER'S INSTRUCTIONS FOR SETTINGS, VERIFY THE DESIRED SETTINGS AND ACTIVATE THE ELECTROSURGICAL UNIT. NOTE: THE MAXIMUM RATED INPUT VOLTAGE FOR THIS DEVICE IS 2KVP-P FOR CUT MODE AND 5 KVP-P FOR COAGULATION MODE." 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.

    Description of Event or Problem · 0

    DURING AN ASCENDING COLON POLYP REMOVAL, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. IT WAS REPORTED [THAT] THE WIRE AT THE DISTAL END OF THE SNARE WAS FOUND TO BE FRACTURED. THE DEVICE WAS IMMEDIATELY REPLACED WITH A NEW COOK SNARE AND THE POLYPECTOMY WAS COMPLETED. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON 10APR2026. IT WAS DETERMINED THAT THE SNARE TIP WAS FRAYED AND THE DEVICE WAS BARELY ABLE TO CUT/COAGULATE THE TISSUE [SUBJECT OF REPORT]. 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
    177507 ACUSNARE POLYPECTOMY SNARE SOFT ENDOSCOPIC ELECTROSURGICAL UNIT AND ACCESSORIES FDI WILSON-COOK MEDICAL INC (COOK ENDOSCOPY) G22632 W4981495 00827002226326

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Female SCOPE, UNKNOWN MAKE AND MODEL.