BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSNARE POLYPECTOMY SOFT SNARE

    MDR report key: 1860410 · Received September 27, 2010

    Report

    Report Number
    1037905-2010-00485
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    August 31, 2010
    Report Date
    August 31, 2010
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNS
    PMA / PMN Number
    K851958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: OUR LAB EVAL OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT OF DIFFICULTY WITH SNARE OPERATION. DURING OUR LAB EVAL, THE SNARE WAS EXTENDED FROM THE OUTER CATHETER AND RETRACTED. MOVEMENT OF THE SNARE WAS POSSIBLE, BUT RESISTANCE WAS ENCOUNTERED. THE OUTER CATHETER EXHIBITS TWO KINKS. THESE KINKS ARE LOCATED 11CM AND 50.5CM FROM THE HANDLE. THE KINKS ARE CREATING RESISTANCE IN MOVEMENT BETWEEN THE SNARE DRIVE WIRE AND THE OUTER CATHETER. THE KINKS IN THE OUTER CATHETER SUGGEST THE SNARE MAY HAVE RECEIVED EXCESSIVE PRESSURE DURING USE OR GENERAL HANDLING. AFTER A REVIEW OF THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED, WE CAN REPORT NO DISCREPANCIES OR ANOMALIES WERE OBSERVED. WE WERE UNABLE TO CONDUCT A SAMPLE TEST FROM THIS LOT BECAUSE NONE OF THE PRODUCT FROM THIS LOT REMAINED IN FINISHED GOODS INVENTORY. A REVIEW OF THE TWELVE MONTH COMPLAINT HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS REMOTE. CONCLUSIONS: A DEFINITIVE CAUSE FOR THIS OBSERVATION WAS UNABLE TO BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LAB SETTING. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PT ANATOMY, ENDOSCOPE POSITION OR PROGRESSION OF DISEASE STATE, WE CANNOT REPRODUCE THE ACTUAL CONDITIONS OF DEVICE USAGE. WHILE CLINICAL CONDITIONS ARE NOT THE SOLE DETERMINING FACTORS, THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE THE CAUSE FOR THIS OBSERVATION. THE INSTRUCTIONS FOR USE DIRECT THE USER TO FULLY RETRACT AND EXTEND THE SNARE TO CONFIRM SMOOTH OPERATION OF THE DEVICE PRIOR TO USE. DIFFICULTY WITH MOVEMENT OF THE SNARE CAN OCCUR IF THE OUTER CATHETER BECOMES KINKED DURING USE OR GENERAL HANDLING, PERHAPS DUE TO AN APPLICATION OF EXCESSIVE PRESSURE. THE INSTRUCTIONS FOR USE FOR THIS PRODUCT LINE ADVISE THE USER TO ADVANCE THE DEVICE IN SHORT INCREMENTS UNTIL ENDOSCOPICALLY VIEWED EXITING THE ENDOSCOPE. THIS ACTIVITY WILL AID IN PRESERVATION OF THE SNARE DEVICE. PRIOR TO DISTRIBUTION, ALL ACUSNARE POLYPECTOMY SNARES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TEST TO ENSURE DEVICE INTEGRITY. THE VISUAL INSPECTION INCLUDES VERIFYING THE DEVICE IS FREE OF KINKS. THE FUNCTIONAL TEST ENSURES THE SNARE MOVES SMOOTHLY AND FREELY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: THE APPROPRIATE PERSONNEL HAVE BEEN INFORMED OF THIS REPORT IN AN EFFORT TO HEIGHTEN AWARENESS. NO FURTHER ACTION WARRANTED AT THIS TIME. 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 FURTHER ACTION IS WARRANTED AT THIS TIME. 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 POLYPECTOMY PROCEDURE A COOK ENDOSCOPY ACUSNARE POLYPECTOMY SOFT SNARE WAS USED. THE USER REPORTED THAT THE SNARE FELT ROUGH AND RIGID IN THE HANDLE WHEN OPENING AND CLOSING THE SNARE. THE POLYPECTOMY SNARE DEVICE IN QUESTION WAS USED TO FINISH THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUSNARE POLYPECTOMY SOFT SNARE KNS, SNARE, FLEXIBLE KNS COOK ENDOSCOPY W2843191

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS CFH180 ENDOSCOPE