BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSNARE POLYPECTOMY SNARE SUPPLIED IN BOXES OF 10

    MDR report key: 1070449 · Received July 3, 2008

    Report

    Report Number
    1037905-2008-00086
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 5, 2008
    Report Date
    June 5, 2008
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    FDI
    PMA / PMN Number
    K851958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: WE WERE UNABLE TO CONFIRM THE REPORT AS IT WAS DESCRIBED, BECAUSE THE AFFECTED PRODUCT WAS NOT RETURNED TO COOK ENDOSCOPY FOR EVAL. HOWEVER, FOUR SEALED DEVICES FROM THE SAME LOT WERE RETURNED FOR EVAL. OUR EVAL OF THE SEALED DEVICES WAS UNABLE TO CONFIRM THE REPORT AS IT WAS DESCRIBED. ALL FOUR HANDLES SECURELY CONNECTED TO AN ACTIVE CORD FROM OUR SHELF STOCK. A VISUAL EXAMINATION OF THE ELECTRICAL PIN INSIDE THE HANDLE ASSEMBLIES CONFIRMED THE COMPONENTS ARE APPROPRIATE (I.E. NO BENDS ARE PRESENT). THE ACUSNARE HANDLES WERE SUBJECTED TO A CONDUCTIVITY TEST USING AN OHM METER AND ACTIVE CORD FROM OUR SHELF STOCK. THE TEST VERIFIED CONTINUOUS CONDUCTIVITY. (THE BUZZER OF THE OHM METER WAS CONTINUOUS.) WHEN ACUSNARES WERE TESTED WITH AN OHM METER BY TOUCHING THE ELECTRICAL PIN AND THE SNARE HEAD, CONTINUOUS CONDUCTIVITY WAS ACHIEVED. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION WAS NOT OBSERVED DURING OUR EVAL. AFTER A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT NUMBER, WE CAN REPORT THAT NO DISCREPANCIES OR ANOMALIES WERE OBSERVED. A REVIEW OF THE TWELVE MONTH COMPLAINT HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. BASED ON THIS INFO, THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS REMOTE. CONCLUSIONS: A DEFINITIVE CAUSE WAS UNABLE TO BE DETERMINED BECAUSE THE ACUSNARE USED DURING THE PROCEDURE WAS NOT RETURNED FOR EVAL, AND THE SEALED PRODUCT FROM THE SAME FUNCTIONED AS INTENDED. INFO PROVIDED IN THE REPORT INDICATES THE USER EXPERIENCED CONNECTION DIFFICULTY WITH THE ACUSNARE HANDLE AND THE ACTIVE CORD. HOWEVER, USE CONTINUED BY MANUALLY HOLDING THE CONNECTION TOGETHER. THE INSTRUCTIONS FOR USE INDICATE THE ACTIVE CORD FITTINGS SHOULD FIT SNUGLY INTO BOTH THE DEVICE HANDLE AND THE ELECTROSURGICAL UNIT. THE USER IS DIRECTED NOT TO USE THE DEVICE IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION. A BEND IN THE ELECTRICAL PIN OF THE ACUSNARE HANDLE COULD CAUSE AN INSECURE CONNECTION AND RESULT IN DIFFICULTY WITH CURRENT APPLICATION. BENDING OF THE ELECTRICAL PIN CAN OCCUR IF CARE IS NOT EXERCISED BY THE USER DURING USE, AND GENERAL HANDLING. IF THE ACTIVE CORD WAS CONNECTED OR REMOVED AT AN ANGLE, THIS COULD HAVE CAUSED THE ARMS OF THE ELECTRICAL IN TO BEND, RESULTING IN CONNECTION DIFFICULTY. BECAUSE THE AFFECTED DEVICE WAS NOT AVAILABLE FOR EVAL, WE WERE UNABLE TO CONFIRM IF THIS CAUSED THE REPORTED CONNECTION DIFFICULTY. PRIOR TO DISTRIBUTION, ALL ACUSNARE POLYPECTOMY SNARES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TEST. THE FUNCTIONAL TEST INCLUDES VERIFICATION OF PROPER CONNECTION TO THE ACTIVE CORD. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: 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 CALCULATION, NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. NO FURTHER ACTION WARRANTED BECAUSE THE REPORT WAS UNABLE TO BE VERIFIED. 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 WITH POLYP REMOVAL, THE USER SELECTED A COOK ENDOSCOPY ACUSNARE POLYPECTOMY SNARE. THE USER ATTEMPTED TO CONNECT THE ACUSNARE TO THE ACTIVE CORD, BUT WAS UNABLE TO ACHIEVE A SECURE CONNECTION. THE ACTIVE CORD WAS CHANGED, AND THE CONNECTION BETWEEN THE ACUSNARE AND THE ACTIVE CORD REMAINED INSECURE. THE USER HELD THE ACTIVE CORD AND ACUSNARE HANDLE TOGETHER, TO SECURE THE CONNECTION DURING THE POLYPECTOMY. THE ACUSNARE WAS USED TO COMPLETE THE PROCEDURE EVEN THOUGH CONNECTION DIFFICULTY WAS EXPERIENCED. A FOREIGN OBJECT DID NOT HAVE TO BE RETRIEVED FROM THE PT. NO ADDITIONAL MEDICAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUSNARE POLYPECTOMY SNARE SUPPLIED IN BOXES OF 10 FDI, SNARE, FLEXIBLE FDI COOK ENDOSCOPY W2521367

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR