BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSNARE POLYPECTOMY SOFT SNARE

    MDR report key: 1942021 · Received November 11, 2010

    Report

    Report Number
    1037905-2010-00597
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 12, 2010
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNS
    PMA / PMN Number
    K851958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: OUR EVAL OF THE DEVICE SAID TO BE INVOLVED CONFIRMED HANDLE RETRACTION DIFFICULTY DUE TO A KINK IN THE HANDLE DRIVE WIRE (WHICH MOVES THROUGH THE HANDLE AND INSIDE THE OUTER CATHETER). THE KINK IN THE HANDLE DRIVE WIRE IS CAUSING RESISTANCE BETWEEN THE DRIVE WIRE AND THE HANDLE COMPONENT, PROHIBITING SHARE MOVEMENT. THE KINK IS ALSO CAUSING RESISTANCE BETWEEN THE DRIVE WIRE AND OUTER CATHETER. THE OUTER CATHETER WAS BUCKLED NEAR THE HANDLE. THE KINK IN THE HANDLE DRIVE WIRE AND BUCKLING OF THE OUTER CATHETER SUGGESTS EXCESSIVE PRESSURE HAD BEEN APPLIED TO THE HANDLE OF THE SNARE. WE WERE UNABLE TO DETERMINE EXACTLY WHEN THE HANDLE DRIVE WIRE BECAME KINKED. 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 PRODUCTS 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 COULD NOT BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PT ANATOMY, ENDOSCOPE POSITION OR PROGRESSION OF DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LAB ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. 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 (I.E. SNARE ADVANCEMENT OR RETRACTION DIFFICULTY) CAN OCCUR IF THE HANDLE DRIVE WIRE AND OUTER CATHETER BECOMES KINKED OR BENT DURING USE OR GENERAL HANDLING, PERHAPS DUE TO AN APPLICATION OF EXCESSIVE PRESSURE. THE KINK IN THE HANDLE DRIVE WIRE AND BUCKLING OF THE OUTER CATHETER SUGGESTS EXCESSIVE PRESSURE HAD BEEN APPLIED TO THE DEVICE DURING USE OR GENERAL HANDLING. 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 ACUSNARE 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 OCCURRENCE IN AN EFFORT TO HEIGHTEN AWARENESS. 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. THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS REMOTE. CUSTOMER QA WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING A POLYPECTOMY, THE PHYSICIAN USED A COOK ENDOSCOPY ACUSNARE POLYPECTOMY SOFT SNARE. HANDLE ACTUATION WAS DESCRIBED AS "SLUGGISH" CREATING DIFFICULTY WITH EXTENSION AND RETRACTION OF THE SNARE FROM THE OUTER CATHETER. THE USER OBSERVED SOME BUCKLING OF THE OUTER CATHETER NEAR THE HANDLE. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THIS DEVICE. 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 SOFT SNARE KNS, SNARE, FLEXIBLE KNS COOK ENDOSCOPY W2899495

    Patients

    Seq Age Sex Outcome Treatment
    1 CONMED BEAMER ELECTROSURGICAL UNIT| OLYMPUS CF H-180 COLONOSCOPE