BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSNARE POLYPECTOMY SNARE

    MDR report key: 2062174 · Received March 18, 2011

    Report

    Report Number
    1037905-2011-00166
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Report Date
    February 16, 2011
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNS
    PMA / PMN Number
    K851958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 AND SAMPLE TEST FROM THIS LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. AFTER A REVIEW OF THE ACCOUNT ORDERING AND SHIPPING HISTORY, THE LOT NUMBER INVOLVED COULD NOT BE DETERMINED. A REVIEW OF THE TWELVE MONTH COMPLAINT HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. THIS REPORT REPRESENTS AN UNUSUAL OCCURRENCE. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS REMOTE. CONCLUSIONS: INFORMATION PROVIDED WITH THIS REPORT INDICATES THE ACUSNARE WAS USED WITHOUT AN ELECTROSURGICAL UNIT. THE INTENDED USE FOR THE ACUSNARE POLYPECTOMY SOFT SNARE LISTED IN THE INSTRUCTIONS FOR USE STATES: "THIS DEVICE IS USED WITH AN ELECTROSURGICAL UNIT FOR ENDOSCOPIC POLYPECTOMY." THE INSTRUCTIONS FOR USE ADVISE THE USER NOT TO USE THIS DEVICE FOR ANY PURPOSE OTHER THAN THE STATED INTENDED USE. USAGE OF THE ACUSNARE DEVICE WITHOUT AN ELECTROSURGICAL UNIT COULD HAVE CONTRIBUTED TO TEARING OF THE MUCOSA. PRIOR TO DISTRIBUTION, ALL ACUSNARE POLYPECTOMY SNARES ARE SUBJECTED TO A VISUAL AND FUNCTIONAL TEST TO ENSURE DEVICE INTEGRITY. THE FUNCTIONAL TEST ENSURES THE SNARE MOVES SMOOTHLY AND FREELY. CORRECTIVE ACTION: NO CORRECTIVE ACTION WARRANTED AT THIS TIME BECAUSE THE INFORMATION PROVIDED INDICATED THE PRODUCT WAS USED IN CONTRADICTION WITH THE INTENDED USE LISTED IN THE INSTRUCTIONS FOR USE AND BECAUSE THE REPORT WAS UNABLE TO BE VERIFIED. THE COMPLAINT RISK PRIORITY NUMBER (CRPN) FOR THIS TYPE OF OCCURRENCE HAS BEEN CALCULATED BASED ON THE RATE OF OCCURRENCE AND SEVERITY OF THE OUTCOME. BASED ON THIS ACTIVITY, NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. THIS OBSERVATION REPRESENTS AN UNUSUAL OCCURRENCE. THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS REMOTE. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. THE PHYSICIAN INDICATED THE SNARE WIRE FEELS "STIFFER AND MORE SPRING LIKE." THE SNARE REPORTEDLY TORE THE MUCOSA DURING USE. 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
    1 ACUSNARE POLYPECTOMY SNARE KNS, SNARE, FLEXIBLE KNS WILSON-COOK MEDICAL INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 FUJINON ENDOSCOPE: UNKNOWN MODEL NUMBER