BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUSNARE POLYPECTOMY SNARE

    MDR report key: 3850459 · Received May 16, 2014

    Report

    Report Number
    1037905-2014-00191
    Event Type
    Injury
    Date Received
    May 16, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 18, 2014
    Manufacturer
    WILLSON-COOK MEDICAL INC
    Product Code
    KNS
    PMA / PMN Number
    K851958
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 CONCLUSIONS: 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 STATES TO "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS, AND BREAKS. IF ANY ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE". THE INSTRUCTIONS FOR USE ALSO STATES : FOLLOWING ELECTROSURGICAL UNIT MFR'S INSTRUCTIONS FOR SETTINGS, VERIFIED DESIRED SETTING AND ACTIVE ELECTROSURGICAL UNIT. NOTE: MAXIMUM RATED INPUT VOLTAGE FOR THIS DEVICE IS 2KVP-P FOR CUT MODE AND 5KVP-P FOR COAGULATION MODE. PRIOR TO THE 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 ISOLATED OCCURRENCE. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED REMOTE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QA 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 AN ENDOSCOPIC MUCOSAL RESECTION (EMR). A COOK ACUSNARE POLYPECTOMY SNARE WAS USED IN THE CECUM TO CLEAN UP THE MARGINS. THE LESION WAS ORIGINALLY 25 MM AND DESCRIBED AS QUITE LARGE. THE PHYSICIAN STATED THE SNARE WORKED UNTIL THE LAST TIME CAUTERY WAS APPLIED. AT THIS TIME THE TIP OF THE SHEATH SEEMED TO COLLAPSE OR BEN SLIGHTLY. THE TIP OF THE SHEATH SEEMED TO DEFORM WHERE CAUTERY WAS BEING APPLIED. WHEN THIS HAPPENED, BLEEDING STARTED. IT IS BELIEVED THE DEVICE CAUSED THE SITE TO BLEED. THE PHYSICIAN USED SOME HEMOSTASIS CLIPS TO STOP. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. OTHER THEN PLACING HEMOSTASIS CLIPS TO STOP THE BLEEDING, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294002 ACUSNARE POLYPECTOMY SNARE KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS WILLSON-COOK MEDICAL INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NP Required Intervention ELECTROSURGICAL UNIT, ACU-1-VL CORD| OLYMPUS COLONOSCOPE (UNK MODEL #), ERBE