BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUSNARE POLYPECTOMY SNARE

    MDR report key: 3934866 · Received June 20, 2014

    Report

    Report Number
    1037905-2014-00249
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 22, 2014
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNS
    PMA / PMN Number
    K851958
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE UNUSED DEVICE FROM A LOT NUMBER THAT DIFFERED FROM THE ONE PROVIDED IN THE REPORT WAS MADE AVAILABLE FOR EVALUATION. (B)(4): MANUFACTURE DATE: 02/31/2014, EXPIRATION DATE 03/31/2017. 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. ONE SEALED DEVICE WAS RETURNED IN THE ORIGINAL PACKAGING. THE DEVICE WAS ADVANCED INTO A PENTAX EC3830-TL COLONOSCOPE IN A SIMULATED LOWER GI POSITION WITH THE TIP IN THE MAXIMUM RETROFLEXED POSITION TO SIMULATE A WORST CASE POSITION. THE SNARE HEAD WAS ADVANCED AND RETRACTED. NO DIFFICULTIES IN ADVANCING OR RETRACTING THE SNARE HEAD WERE OBSERVED AND THE SNARE HEAD WAS MANIPULATED SMOOTHLY WITH AN EXPECTED AMOUNT OF FORCE AT THE USER HANDLE. THE SNARE HEAD AND HANDLE WERE EXAMINED FOR ANY DEFECTS THAT MIGHT CAUSE A DIFFICULTY IN ADVANCEMENT OR A SUDDEN MOVEMENT OF THE SNARE HEAD. NO SUCH DEFECTS WERE OBSERVED. THE ADJUSTABLE MARKER IN THE HANDLE WAS PRESENT AND FUNCTIONED NORMALLY, SLIDING UP AND DOWN; THEREFORE, THIS DEVICE FUNCTIONED AS INTENDED. THE DEVICE HISTORY RECORD FOR THE SEALED LOT NUMBER WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. PRIOR TO DISTRIBUTION, ALL POLYPECTOMY SNARES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE TWO RELATED DEVICE HISTORY RECORDS CONFIRMED THAT BOTH LOTS MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. 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 · 1

    DURING A COLONOSCOPY PROCEDURE, WHILE ADVANCING THE ACUSNARE POLYPECTOMY SNARE OUT OF THE CATHETER, THE SNARE "JUMPED" AND A SCRAPE WAS OBSERVED TO THE MUCOSA FOLDS, TO THE RIGHT OF THE POLYPECTOMY SITE. LATER THAT DAY, THE PATIENT WENT TO THE EMERGENCY ROOM WITH FEVER AND CHILLS. THE PATIENT UNDERWENT LAPAROSCOPY AND A PERFORATION WAS OBSERVED (NOT AT THE POLYPECTOMY SITE). NO SECTION OF THE DEVICE DETACHED INSIDE THE PATIENT. THE PATIENT UNDERWENT EXPLORATORY LAPAROSCOPIC SURGERY. LAPAROSCOPIC EXPLORATION INDICATED A PERFORATION IN THE LOCATION OF THE SCRAPE BESIDE THE POLYP THAT HAD BEEN REMOVED. THE PATIENT WAS ADMITTED TO INTENSIVE CARE UNDERGOING TREATMENT FOR SEPTIC SHOCK. ON (B)(6), WE CONFIRMED THE PATIENT WAS DOING BETTER AND OFF INTUBATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364209 ACUSNARE POLYPECTOMY SNARE KNS WILSON-COOK MEDICAL INC W3357406

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L OLYMPUS ENDOSCOPE: MODEL NUMBER UNK| BOSTON SCIENTIFIC CAPTIFLEX SNARE| ERBE ELECTROSURGICAL UNIT