BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COTTON CANNULATOME

    MDR report key: 20945654 · Received December 16, 2024

    Report

    Report Number
    1037905-2024-00814
    Event Type
    Malfunction
    Date Received
    December 16, 2024
    Date of Event
    November 18, 2024
    Report Date
    December 16, 2024
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K172665. 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. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSION: 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. A BROKEN CUTTING WIRE CAN OCCUR IF THE TIP OF THE DEVICE IS OVER FLEXED. THE INSTRUCTIONS FOR USE CAUTION THE USER WITH THE FOLLOWING COMMENT: ¿DO NOT OVER FLEX OR BOW THE TIP BEYOND 90 DEGREES, AS THIS MAY DAMAGE OR CAUSE THE CUTTING WIRE TO BREAK.¿ IF THE SPHINCTEROTOME IS USED WITH EXCESSIVE ELECTROSURGICAL CURRENT SETTINGS PROVIDED BY THE ELECTROSURGICAL UNIT, THIS CAN CONTRIBUTE TO CUTTING WIRE BREAKAGE. THE INSTRUCTIONS FOR USE FOR THIS SPHINCTEROTOME DIRECT THE USER WITH THE COMMENT: ¿BEFORE USING THIS DEVICE, FOLLOW RECOMMENDATIONS PROVIDED BY THE ELECTROSURGICAL UNIT MANUFACTURER TO ENSURE PATIENT SAFETY THROUGH PROPER PLACEMENT AND UTILIZATION OF THE PATIENT RETURN ELECTRODE. ENSURE A PROPER PATH FROM THE PATIENT RETURN ELECTRODE TO THE ELECTROSURGICAL UNIT IS MAINTAINED THROUGHOUT THE PROCEDURE.¿ THE INSTRUCTIONS FOR USE ALSO INSTRUCTS THE USER WITH THE COMMENT: ¿ADVANCE THE TIP OF SPHINCTEROTOME INTO THE ENDOSCOPE ACCESSORY CHANNEL AND CONTINUE TO ADVANCE IN SHORT INCREMENTS UNTIL THE DEVICE IS ENDOSCOPICALLY VISIBLE.¿ PRIOR TO DISTRIBUTION, ALL CLASSIC COTTON CANNULATOMES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING 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. THERE HAVE BEEN NO OTHER SIMILAR OCCURRENCES REPORTED DURING THE TIME PERIOD REVIEWED. THEREFORE, THIS REPORT REPRESENTS AN ISOLATED OCCURRENCE. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS RARE. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 0

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK COTTON CANNULATOME. IT WAS REPORTED THAT THE CUTTING WIRE BROKE OFF MID-PROCEDURE AND THEY [PHYSICIAN AND TEAM] WERE UNABLE TO LOCATE THE FRAGMENT. THE SCOPE WAS SENT OUT FOR SERVICE TO SEE IF THE WIRE IS IN THE CHANNEL. ACCORDING TO THE INITIAL REPORTER, THE CUTTING WIRE BROKE OFF MID-PROCEDURE AND THEY WERE UNABLE TO LOCATE THE FRAGMENT. IT IS THOUGHT TO BE IN THE ENDOSCOPE. THEY HAVE SENT THE SCOPE TO OLYMPUS FOR SERVICING AND WILL BE GETTING A REPORT ON IF THEY FOUND THE LOST CUTTING WIRE. NO FURTHER INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, AND IT WAS STATED THAT THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2355428 COTTON CANNULATOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS WILSON-COOK MEDICAL INC G22732 W4844716

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male COOK GT-1-E ERCP CATHETER| COOK METII-600E WIRE GUIDE| COOK PC-7E STENT INTRODUCER| COOK TXR-ME EXTRACTION BALLOON| COOK ZSO-7-7 STENTS| GORE VIABL METAL STENT 10MM X6CM| OLYMPUS PEDIATRIC COLONOSCOPE