BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSNARE POLYPECTOMY SNARE

    MDR report key: 18111562 · Received November 10, 2023

    Report

    Report Number
    1037905-2023-00554
    Event Type
    Malfunction
    Date Received
    November 10, 2023
    Report Date
    November 10, 2023
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNS
    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

    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: BASED ON THE INFORMATION PROVIDED THE PATIENT HAD INCOMPLETE RESECTION OF THE POLYPS. INCOMPLETE RESECTION IS A KNOWN CLINICAL COMPLICATION. THERE IS NO EVIDENCE TO SUGGEST THE REPORT IS DUE TO A DEVICE FAILURE. THE ADDITIONAL INFORMATION PROVIDED BY THE USER STATED THAT A COLD POLYPECTOMY WAS PERFORMED TWO TIMES. THIS IS AGAINST THE INTENDED USE OF THE DEVICE. THE INTENDED USE FOR THIS DEVICE STATES: "THIS DEVICE IS USED WITH AN ELECTROSURGICAL UNIT FOR ENDOSCOPY POLYPECTOMY. . .DO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN THE STATED INTENDED USE." THIS IS THE MOST LIKELY CAUSE OF THE REPORT ON TWO OCCASIONS. 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. 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

    COOK ENDOSCOPY WAS NOTIFIED OF THIS EVENT THROUGH A PMCF STUDY REPORT. PLEASE SEE BELOW FOR RELEVANT EXCERPTS OF THE REPORT. "...COMPLETE RESECTION OF POLYPS WAS OBSERVED AMONG 98.5% (95% CI: 95.9%, 99.7%) OF PATIENTS... OUTCOME: PERFORMANCE OUTCOME-SUCCESSFUL COMPLETE RESECTION OF THE POLYP % (N/N) ALL (95% CI) : 99.5%, 1017/1022, 98.%, 99.9% COLD SNARE (95%CI): 99.3%, 271/273, (97.1%, 99.9%) HOT SNARE (95% CI): 99.6%, 746/749, (98.7%, 99.9%) NO ADVERSE EVENTS WERE REPORTED DURING THE PROCEDURE OR 21-DAY FOLLOW-UP. NO PATIENT DEATHS WERE REPORTED DURING 21-DAY FOLLOW-UP AFTER POLYPECTOMY DEVICE USE. ... EVENTS WERE DEEMED NOT RELATED TO THE STUDY DEVICE." THE SUBJECT OF THIS REPORT IS 5 INCOMPLETE RESECTIONS. WHILE IT IS NOT SPECIFIED IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS OR REQUIRED ADDITIONAL MEDICAL PROCEDURES DUE TO THIS EVENT, THE INFORMATION ABLE TO BE COLLECTED DOES NOT REASONABLY SUGGEST THE PATIENT WAS ADVERSELY IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1804150 ACUSNARE POLYPECTOMY SNARE KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS WILSON-COOK MEDICAL INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ENDOSCOPE - UNKNOWN MAKE AND MODEL