BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME

    MDR report key: 1881379 · Received October 7, 2010

    Report

    Report Number
    1037905-2010-00487
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    August 27, 2010
    Report Date
    September 9, 2010
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNS
    PMA / PMN Number
    K052051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: OUR EVALUATION OF THE RETURNED DEVICE CONFIRMED THE REPORT. AFTER VIEWING THE TIP UNDER MAGNIFICATION, A VERY SMALL SECTION OF THE CATHETER TUBING MATERIAL HAS PEELED BACK FROM DOME SHAPED TIP. THE PEELED AREA IS LOCATED NEAR THE BASE OF THE DOME TIP AT THE DISTAL END OF THE SPHINCTEROTOME. THE MATERIAL REMAINS ATTACHED AND EXTENDS OUTWARD APPROXIMATELY 0.2MM. BECAUSE THE SPHINCTEROTOME TIP IS INSPECTED FOR SPLITS PRIOR TO DISTRIBUTION, THE PEELING AREA MAY HAVE OCCURRED DURING PRODUCT HANDLING AND/OR PRODUCT USAGE. THE CUTTING WIRE IS INTACT AND DOES NOT EXHIBIT EVIDENCE OF A CAUTERY APPLICATION (NO BLACKENING OF THE CUTTING WIRE WAS NOTED). 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 12 MONTH COMPLAINT HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. THIS REPORT REPRESENTS AN UNUSUAL OCCURRENCE. 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 PATIENT ANATOMY, ENDOSCOPE POSITION OR PROGRESSION OF DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LABORATORY ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. DAMAGE TO THE TIP OF THE SPHINCTEROTOME CAN OCCUR IF THE SPHINCTEROTOME RECEIVED EXCESSIVE PRESSURE DURING ADVANCEMENT OF THE CATHETER THROUGH THE ACCESSORY CHANNEL OF THE ENDOSCOPE. IF THE ELEVATOR OF THE ENDOSCOPE HAS AN ABNORMALLY SHARP EDGE, THIS COULD CONTRIBUTE TO A DAMAGED TIP. THIS SPHINCTEROTOME CATHETER IS PRE-CURVED AND IS PROVIDED WITH A PRE-CURVED STYLET IN THE DISTAL TIP OF THE CATHETER. THIS OBVIATES THE NEED FOR MANUAL FORMATION. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING COMMENT: "NOTE: DO NOT APPLY MANUAL PRESSURE TO TIP OR CUTTING WIRE OF THE SPHINCTEROTOME TO INFLUENCE ORIENTATION, AS THIS MAY RESULT IN DAMAGE TO DEVICE." OTHER FACTORS THAT CAN CONTRIBUTE TO A DAMAGED TIP INCLUDE MANIPULATING THE HANDLE WITH THE PRE-CURVED STYLET INSIDE THE CANNULATING TIP. THE INSTRUCTIONS FOR USE ADVISE THE USER TO CAREFULLY REMOVE THE PRE-CURVED STYLET FROM THE CANNULATING TIP. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING COMMENT: "NOTE: DO NOT EXERCISE HANDLE WHILE DEVICE IS COILED OR PRE-CURVED STYLET IS IN PLACE, AS THIS MAY CAUSE DAMAGE TO SPHINCTEROTOME AND RENDER IT INOPERABLE." PRIOR TO DISTRIBUTION, ALL FUSION OMNI-TOME SPHINCTEROTOMES ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. THE VISUAL INSPECTION VERIFIES THE TIP IS ROUND WITH NO SHARP EDGES. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THIS LOT MET MANUFACTURING 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 FURTHER ACTION IS WARRANTED AT THIS TIME. THIS OBSERVATION REPRESENTS AN UNUSUAL OCCURRENCE. 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 AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN SELECTED A COOK ENDOSCOPY FUSION OMNI-TOME SPHINCTEROTOME. THE SPHINCTEROTOME WAS ADVANCED THROUGH THE ACCESSORY CHANNEL OF THE ENDOSCOPE. ONCE THE SPHINCTEROTOME TIP EXITED THE ENDOSCOPE INSIDE THE PATIENT, THE PHYSICIAN NOTICED THAT THE TIP OF THE SPHINCTEROTOME WAS NOT SMOOTH AND A SMALL SECTION WAS PROTRUDING FROM THE CATHETER NEAR THE DISTAL END. THE SPHINCTEROTOME WAS REMOVED FROM THE PATIENT AND ANOTHER SPHINCTEROTOME WAS USED TO PERFORM THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL MEDICAL PROCEDURES DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME KNS, ENDOSCOPIC ELECTROSURGICAL UNIT AND ACCESSORIES KNS COOK ENDOSCOPY W2892143

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS "V" ENDOSCOPE: MODEL #UNK