BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUSION OMNI-TOME

    MDR report key: 18131121 · Received November 14, 2023

    Report

    Report Number
    1037905-2023-00564
    Event Type
    Injury
    Date Received
    November 14, 2023
    Date of Event
    October 2, 2023
    Report Date
    November 14, 2023
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNS
    UDI-DI
    10827002319032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K172288. 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: ¿DO NOT OVER FLEX OR BOW THE TIP BEYOND 90 DEGREES, AS THIS MAY DAMAGE OR CAUSE THE CUTTING WIRE TO BREAK.¿ CUTTING WIRE BREAKAGE CAN OCCUR IF THE HANDLE IS MANIPULATED WITH THE CATHETER IN A COILED POSITION OR WITH THE PRECURVED STYLET INSIDE THE CANNULATING TIP. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING PRECAUTION: "DO NOT EXERCISE THE HANDLE WHILE THE DEVICE IS COILED OR THE PRECURVED STYLET IS IN PLACE, AS THIS MAY CAUSE DAMAGE TO THE SPHINCTEROTOME AND RENDER IT INOPERABLE." THE INSTRUCTIONS FOR USE ADVISE THE USER WITH THE FOLLOWING STATEMENT: ¿UPON REMOVING THE DEVICE FROM THE PACKAGE, UNCOIL AND STRAIGHTEN SPHINCTEROTOME. CAREFULLY REMOVE THE PRECURVED STYLET FROM THE CANNULATING TIP.¿ IF THE ELEVATOR OF THE ENDOSCOPE REMAINS IN THE CLOSED/UP POSITION WHEN RETRACTION OF THE SPHINCTEROTOME IS ATTEMPTED AND ADDITIONAL PRESSURE IS APPLIED, THIS COULD CONTRIBUTE TO CUTTING WIRE BREAKAGE. THE INSTRUCTIONS FOR USE CAUTION THE USER: "THE ELEVATOR SHOULD REMAIN OPEN/DOWN WHEN ADVANCING OR RETRACTING THE SPHINCTEROTOME.¿ THIS ACTIVITY WILL AID IN DEVICE PRESERVATION. PRIOR TO DISTRIBUTION, ALL FUSION OMNI-TOMES 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: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. 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 · 0

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION OMNI-TOME. IT WAS INITIALLY REPORTED THAT DURING THE PROCEDURE THE SPHINCTEROTOME BROKE DURING SPHINCTEROTOMY AND A PIECE OF THE CUTTING WIRE REMAINED IN PATIENTS AMPULLA. THE PATIENT WENT TO ITU (INTENSIVE THERAPY UNIT). ADDITIONAL INFORMATION WAS RECEIVED ON 27 OCT 2023 STATING THAT THE INITIAL GUIDE WIRE WENT TO PD [PANCREATIC DUCT]. HENCE, A PANCREATIC SPHINCTEROTOMY WAS PERFORMED. THEN CBD [COMMON BILE DUCT] CANNULATION. NARROWED DUCT 7MM WITH NO OBVIOUS STONES. THEN, SPHINCTEROTOME WAS BROKEN. SWITCHED TO GASTROSCOPE TO RETRIEVE BROKEN SPHINCTEROTOME. PHYSICIAN PERFORMED REMAINDER OF THE PROCEDURE. REINTUBATION AND CANNULATION, BALLOON TRAWL 8.5MM WITH NO STONES. GOOD DRAINAGE OF BILE AND CLEAR DUCT ON OCCLUSION CHOLANGIOGRAM. A PIECE OF THE CUTTING WIRE REMAINED IN PATIENT¿S AMPULLA. RETRIEVAL WAS ATTEMPTED WITH BIOPSY FORCEPS BUT ON CT A 5MM SECTION REMAINED IMBEDDED IN THE AMPULLA. THE PHYSICIAN SWITCHED TO GASTROSCOPE TO RETRIEVE BROKEN SPHINCTEROTOME. PHYSICIAN PERFORMED REMAINDER OF THE PROCEDURE. PER INITIAL REPORTER, NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1977618 FUSION OMNI-TOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS WILSON-COOK MEDICAL INC W4735017 10827002319032

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Required Intervention COOK AWG2-35-260 WIRE GUIDE| PENTAX DUODENOSCOPE, MODEL UNKNOWN| PENTAX GASTROSCOPE EG29-I10