BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COTTON CANNULATOME

    MDR report key: 2230595 · Received August 11, 2011

    Report

    Report Number
    1037905-2011-00526
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 2011
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNS
    PMA / PMN Number
    K901443
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO IN THIS REPORT WAS PROVIDED TO US BY THE COOK FACILITY IN (B)(4) ON BEHALF OF A MEDICAL FACILITY IN (B)(6). (B)(6). (B)(4). EVAL: AS PART OF THIS COMPLAINT INVESTIGATION, RETURN OF THE PRODUCT FOR EVAL WAS REQUESTED. THE INITIAL REPORTER INDICATED THE PRODUCT SAID TO BE INVOLVED WILL NOT BE RETURNED. THEREFORE, A PRODUCT EVAL WAS NOT PERFORMED IN RESPONSE TO THIS REPORT AND THE REPORT COULD NOT BE CONFIRMED. THE POSSIBLE LOT NUMBERS OF THE PRODUCT SAID TO BE INVOLVED WERE USED TO REVIEW THE DEVICE HISTORY RECORDS. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. A SAMPLE TEST FROM THIS LOT COULD NOT BE CONDUCTED BECAUSE NONE OF THE PRODUCT FROM THESE LOTS REMAINED IN INVENTORY. CORRECTIVE ACTION: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVAL. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. A BROKEN CUTTING WIRE CAN OCCUR IF THE TIP OF THE DEVICE IS OVER FLEXED. THE INSTRUCTIONS FOR USE CAUTION THE USER NOT TO OVER FLEX OR BOW THE TIP BEYOND 90 DEGREES, AS THIS MAY DAMAGE THE SPHINCTEROTOME. CUTTING WIRE BREAKAGE CAN OCCUR IF THE HANDLE IS MANIPULATED 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 WHILE DEVICE IS COILED OR PRE-CURVED STYLET IS IN PLACE, AS THIS MAY CAUSE DAMAGE TO SPHINCTEROTOME AND RENDER IT INOPERABLE." CUTTING WIRE BREAKAGE CAN ALSO OCCUR IF THE CUTTING WIRE MAKES CONTACT WITH THE ENDOSCOPE WHEN ELECTROSURGICAL CURRENT IS APPLIED TO PERFORM THE SPHINCTEROTOMY. THE INSTRUCTIONS FOR USE CAUTION THE USER TO ENSURE THE CUTTING WIRE IS COMPLETELY OUT OF THE ENDOSCOPE WHEN APPLYING ELECTROSURGICAL CURRENT. THE INSTRUCTIONS CAUTION THE USER THAT CONTACT OF THE CUTTING WIRE WITH THE ENDOSCOPE COULD RESULT IN BREAKAGE OF THE CUTTING WIRE. PRIOR TO DISTRIBUTION, ALL COTTON CANNULA TOME SPHINCTEROTOMES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TEST TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE POSSIBLE LOT NUMBERS CONFIRMED THAT THE LOTS SAID TO BE INVOLVED MET ALL MFG REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THIS TYPE OF REPORT REPRESENTS AN UNUSUAL OCCURRENCE. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS AREA. QA WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK COTTON CANNULA TOME. WHEN PRESSURE WAS APPLIED TO THE SPHINCTEROTOME HANDLE TO PERFORM THE SPHINCTEROTOMY, THE CUTTING WIRE BROKE AND DETACHED FROM THE CATHETER TIP. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE CUTTING WIRE WITH SUCTION FROM THE ENDOSCOPE. THE ENDOSCOPE WAS REMOVED FROM THE PT IN HOPES THAT THE CUTTING WIRE WAS REMOVED SUCCESSFULLY, BUT THIS WAS NOT THE CASE. AN X-RAY WAS TAKEN IN AN ATTEMPT TO CONFIRM IF THE CUTTING WIRE WAS REMOVED SUCCESSFULLY. THE X-RAY WAS INCONCLUSIVE. IT IS POSSIBLE A SECTION OF THE DEVICE REMAINED INSIDE THE PT'S BODY. THE PT REQUIRED AN X-RAY, BLOOD CONTROL AND MONITORING 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 COTTON CANNULATOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS WILSON-COOK MEDICAL INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention FUJINON ENDOSCOPE (UNK MODEL NUMBER)| ERBE ELECTROSURGICAL UNIT| ACTIVE CORD (UNK TYPE)