BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSNARE POLYPECTOMY SNARE

    MDR report key: 12396317 · Received August 31, 2021

    Report

    Report Number
    1037905-2021-00461
    Event Type
    Malfunction
    Date Received
    August 31, 2021
    Date of Event
    August 4, 2021
    Report Date
    August 31, 2021
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    510(K): K191048. 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. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. 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. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING INFORMATION TO ASSIST WITH PROPER SET-UP AND USE OF THE DEVICE: "BEFORE USING THIS DEVICE, FOLLOW RECOMMENDATIONS PROVIDED BY ELECTROSURGICAL UNIT MANUFACTURER TO ENSURE PATIENT SAFETY THROUGH PROPER PLACEMENT AND UTILIZATION OF PATIENT RETURN ELECTRODE. ENSURE A PROPER PATH FROM PATIENT RETURN ELECTRODE TO ELECTROSURGICAL UNIT IS MAINTAINED THROUGHOUT THE PROCEDURE." PRIOR TO DISTRIBUTION, ALL ACUSNARE POLYPECTOMY SNARES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED AND THIS REPRESENTS AN UNUSUAL OCCURRENCE. 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 · 1

    DURING A POLYPECTOMY PROCEDURE, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. A LARGE POLYP WAS BEING SNARED AND DURING SNARING, THE SNARE EVENTUALLY GOT TO THE POINT THAT IT WOULD NO LONGER CUT EVEN THOUGH CURRENT WAS BEING APPLIED. THE CUSTOMER WAS INSTRUCTED BY THE COOK CLINICAL SPECIALIST TO ATTEMPT TO OPEN AND CLOSE THE SNARE AND CONTINUE TO SNARE THE POLYP. THIS OPENING AND CLOSING ALLOWED THEM TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH THE DEVICE IN QUESTION. THE CUSTOMER FELT THAT THERE WAS AN ABNORMAL AMOUNT OF SMOKE IN THE ENDOSCOPIC FIELD OF VIEW. 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
    1298074 ACUSNARE POLYPECTOMY SNARE KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS COOK ENDOSCOPY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1