BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSNARE POLYPECTOMY SNARE

    MDR report key: 19851139 · Received July 29, 2024

    Report

    Report Number
    1037905-2024-00418
    Event Type
    Malfunction
    Date Received
    July 29, 2024
    Date of Event
    June 12, 2024
    Report Date
    July 29, 2024
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    FDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION G: PMA/510(K): K173673 INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. 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: 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. 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)." 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: 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

    DURING A COLONOSCOPY, THE PHYSICIAN USED TWO COOK ACUSNARE POLYPECTOMY SNARE. IT WAS REPORTED [THAT] THE HANDLE WAS CONNECTED TO THE ELECTROCAUTERY DEVICE, TURNED ON 15 [WATTS] (CUTTING AND COAGULATION). HOWEVER, THE MATERIAL DID NOT CAUTERIZE THE INJURY AND MELTED THE PLASTIC PART IN THE CONNECTION BETWEEN THE HANDLE EXTENSION AND THE RACK. 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
    369850 ACUSNARE POLYPECTOMY SNARE FDI, SNARE, FLEXIBLE FDI WILSON-COOK MEDICAL INC W4745295

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female UNKNOWN ENDOSCOPE