BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 3988064 · Received June 13, 2014

    Report

    Report Number
    1037905-2014-00243
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Report Date
    May 15, 2014
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL COMMENTS REGARDING THIS REPORT: THE FOLLOWING POTENTIAL CATALOG NUMBERS WERE PROVIDED: DASH-ACRO-25-450 (PMA/510(K) # K901443); MT-20M (PMA/510(K) # K901443); FS-OMNI-21 (PMA/510(K) # K052051); FS-OMNI-21-480 (PMA/510(K) # K052051); FS-OMNI-21-260 (PMA/510(K) # K052051). INVESTIGATION EVALUATION: 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. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSIONS: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. IMPROPER CUTTING WIRE ORIENTATION CAN OCCUR IF THE DISTAL END OF THE CATHETER IS SHAPED MANUALLY. 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 IMPROPER CUTTING WIRE ORIENTATION INCLUDE MANIPULATING THE HANDLE WITH THE CATHETER IN A COILED POSITION OR WITH THE PRE-CURVED STYLET INSIDE THE CANNULATING TIP. THE INSTRUCTIONS FOR USE ADVISE THE USER TO UNCOIL AND STRAIGHTEN THE SPHINCTEROTOME UPON REMOVING THE DEVICE FROM THE PACKAGING. THE USER IS THEN INSTRUCTED TO CAREFULLY REMOVE THE PRE-CURVED STYLET FROM THE CANNULATING TIP. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING COMMENT: "NOTE: DO NOT EXERCISE HANDLE WHITE 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 COOK SPHINCTEROTOMES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TEST TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACT!ON: 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

    THE CUSTOMER REPORTED THAT THEY HAVE HAD MULTIPLE INCIDENCES INVOLVING INCORRECT SPHINCTEROTOME ORIENTATION. THIS HAS OCCURRED WITH VARYING COOK SPHINCTEROTOME RE ORDER NUMBERS. ADDITIONAL INFORMATION WAS REQUESTED AND A SPECIFIC QUANTITY COULD NOT BE PROVIDED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350830 UNK KNS, UNIT, ELECTROSURGERY, ENDOSCOPIC, (WITH OR WITHOUT ACCESSORIES) KNS WILSON-COOK MEDICAL INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 BOSTON JAGTOME RX 39 (UNK MODEL NUMBER)| OLYMPUS THERAPEUTIC DOUDENOSCOPE ENDOSCOPE-| (UNK MODEL NUMBER)