BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSNARE POLYPECTOMY SNARE

    MDR report key: 20213842 · Received September 13, 2024

    Report

    Report Number
    1037905-2024-00540
    Event Type
    Malfunction
    Date Received
    September 13, 2024
    Date of Event
    July 11, 2024
    Report Date
    September 13, 2024
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    FDI
    UDI-DI
    00827002226319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K): SECTION G: K173673. INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS PERFORMED ONLY BY THE VIDEO PROVIDED WITH THIS REPORT BECAUSE THE PRODUCTS SAID TO BE INVOLVED WERE NOT PROVIDED TO COOK FOR EVALUATION. A PHOTO OF THE LOT NUMBER WAS NOT PROVIDED. THE VIDEO PROVIDED SHOWS ONE DEVICE COILED IN 3 LOOPS ON A TABLE TOP, THE SNARE HEAD IS BEING ADVANCED AND RETRACTED, AND IT APPEARS THERE IS SOME RESISTANCE IN BOTH ADVANCEMENT AND RETRACTION OF THE SNARE HEAD, CONFIRMING THE CUSTOMER'S COMPLAINT. 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 VIDEO CONFIRMED THE REPORT OF RESISTANCE, HOWEVER, 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 SETUP AND USE OF THE DEVICE: "FULLY RETRACT AND EXTEND THE SNARE TO CONFIRM SMOOTH OPERATION OF THE DEVICE." ADDITIONALLY, THE INSTRUCTIONS FOR USE STATES "FOLLOWING THE ELECTROSURGICAL UNIT MANUFACTURER'S INSTRUCTIONS FOR SETTINGS, VERIFY THE DESIRED SETTINGS AND ACTIVATE THE ELECTROSURGICAL UNIT....SECURELY CONNECT THE ACTIVE CORD TO THE DEVICE HANDLE AND ELECTROSURGICAL USE....PROCEED WITH THE POLYPECTOMY, UPON COMPLETION OF THE POLYPECTOMY, TURN THE ELECTROSURGICAL UNIT OFF." 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 AN ENDOSCOPIC PROCEDURE IN SIGMOID COLON, THE PHYSICIAN USED FOUR COOK ACUSNARE POLYPECTOMY SNARE[S]. IT WAS REPORTED THAT WHEN INSERTING IT [SNARES] INTO THE CAVITY AND TRYING TO COLLECT THE FRAGMENT, THERE IS RESISTANCE (SOMETIMES TO APPLICATION AND LATER TO RETRACTION) AND LOCKING AT THE MOMENT OF TWISTING, AND SHE IS UNABLE TO COLLECT THE FRAGMENT. CUSTOMER PROVIDED VIDEO SHOWING RESISTANCE WHEN ADVANCING AND RETRACTING THE SNARE. 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
    1112922 ACUSNARE POLYPECTOMY SNARE FDI, SNARE, FLEXIBLE FDI WILSON-COOK MEDICAL INC W4789729 00827002226319

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female FIJIFIL- EP 6000 ENDOSCOPE