BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSNARE POLYPECTOMY SNARE SOFT

    MDR report key: 17316596 · Received July 13, 2023

    Report

    Report Number
    1037905-2023-00336
    Event Type
    Malfunction
    Date Received
    July 13, 2023
    Date of Event
    May 23, 2023
    Report Date
    July 13, 2023
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNS
    UDI-DI
    00827002226333
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION REGARDING ALL MANUFACTURERS SECTION PMA/510(K): K851958. 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. 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 COLONIC POLYP REMOVAL, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE SOFT. IT WAS REPORTED [THAT THE] USER TOOK SNARE TO CONDUCT COLONIC POLYPS REMOVAL PROCEDURE, AFTER SUCCESSFULLY REMOVED FIRST POLYP AND READY TO REMOVE SECOND ONE WHILE FINDING OUT THE WIRE AT HANDLE BROKEN. USER THEN CHANGED TO ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE WHICH CAUSE 10 MINUTES DELAY IN PROCEDURE. 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
    2209582 ACUSNARE POLYPECTOMY SNARE SOFT KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS WILSON-COOK MEDICAL INC G22633 W4689450 00827002226333

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male ENDOSCOPE - UNKNOWN MAKE AND MODEL