BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSNARE POLYPECTOMY SNARE

    MDR report key: 14277797 · Received May 4, 2022

    Report

    Report Number
    1037905-2022-00200
    Event Type
    Malfunction
    Date Received
    May 4, 2022
    Date of Event
    April 5, 2022
    Report Date
    May 3, 2022
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNS
    UDI-DI
    00827002227002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    510K: K851958. 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 WAS RETURNED WITH THE SNARE RETRACTED BEYOND THE DISTAL TIP OF THE CATHETER. DURING A VISUAL INSPECTION, THE HANDLE CANNULA WAS RETRACTED AND THE DRIVE WIRE WAS EXPOSED IN THE HANDLE SLOT. THE HOT PIN WAS LOOSE. A CLOSE VISUAL EXAMINATION OF THE PROXIMAL END OF THE HANDLE CANNULA SHOWED AN INDENTATION INDICATING THE DRIVE WIRE HAD BEEN TORQUED. IT IS UNKNOWN HOW OR WHEN THE HOT PIN BECAME LOOSE. A FUNCTION TEST WAS NOT POSSIBLE, DUE TO THE CONDITION OF THE DEVICE. WHEN THE DRIVE WIRE WAS MANIPULATED MANUALLY WITH PLIERS, THE SNARE HEAD WOULD ADVANCE AND RETRACT. 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: 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. 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 REMOTE. 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 A COOK ACUSNARE POLYPECTOMY SNARE. IT WAS REPORTED THAT WIRE WAS PROTRUDING FROM THE [SNARE] HANDLE. 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
    1501132 ACUSNARE POLYPECTOMY SNARE KNS, ENDOSCOPIC ELECTROSURGICAL UNIT AND ACCESSORIES KNS WILSON-COOK MEDICAL INC G22700 W4562945 00827002227002

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ENDOSCOPE - OLYMPUS PCF-H190L