BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME

    MDR report key: 14014224 · Received April 5, 2022

    Report

    Report Number
    1037905-2022-00157
    Event Type
    Malfunction
    Date Received
    April 5, 2022
    Date of Event
    February 15, 2022
    Report Date
    April 5, 2022
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNS
    UDI-DI
    00827002558151
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K172288. INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED DETERMINED VIA VISUAL INSPECTION OF THE CATHETER THAT THE DISTAL TIP OF THE DEVICE APPEARS TO BE DISTORTED/DAMAGED. IT IS NOT KNOWN AT WHAT POINT THE DISTAL TIP BECAME DISTORTED/DAMAGED. NO SECTION OF THE SPHINCTEROTOME DEVICE APPEARED TO BE MISSING. DURING THE LABORATORY EVALUATION THE HANDLE AND DRIVE WIRE FUNCTIONED AS INTENDED AND COMPLETELY BOWED THE DISTAL TIP OF THE CATHETER. A BROWN LIQUID WAS OBSERVED INSIDE OF THE CATHETER NEAR THE DISTAL END AND A CLEAR LIQUID WAS OBSERVED THROUGHOUT THE DEVICE. A PRODUCT DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS REPORTED OCCURRENCE WAS NOT OBSERVED. DEVICES RELEASED FOR DISTRIBUTION GO THROUGH MULTIPLE INSPECTIONS TO DETECT SUCH DEFECTS. INSPECTIONS INCLUDE CONFIRMATION OF ADEQUATE TIP BOWING, A VISUAL INSPECTION TO CONFIRM PROPER FORMING OF THE DOME SHAPE TIP, AND PROPER INSERTION OF THE SHAPING WIRE AT THE DISTAL END. THEREFORE, IT IS UNKNOWN HOW OR AT WHAT POINT THE TIP OF THE CATHETER BECAME DAMAGED/DISTORTED. 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: THE CAUSE OF THE DEFORMATION OF THE DISTAL TIP OF THE DEVICE IS UNKNOWN. HOWEVER, IT IS POSSIBLE THAT THE TIP WAS DEFORMED DUE TO CONTACT WITH AN EXTERNAL FORCE. THE PROPOSED SOURCE OF THE EXTERNAL FORCE TO THE CATHETER IS UNKNOWN. EVIDENCE OF A MANUFACTURING NONCONFORMITY WAS NOT OBSERVED. THE INSTRUCTIONS FOR USE ALSO ADVISE THE USER TO: ¿VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE." PRIOR TO DISTRIBUTION, ALL FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOMES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TEST TO ENSURE DEVICE INTEGRITY. THE FUNCTIONAL TEST INCLUDES BOWING THE SPHINCTEROTOME TO ENSURE THE DISTAL END RESPONDS TO HANDLE MANIPULATION. 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

    IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. IT WAS INITIALLY REPORTED THAT UPON INSPECTION, THE TIP OF THE SPHINCTEROTOME WAS CRACKED. THEY SIMPLY OPENED ANOTHER DEVICE AND CONTINUED WITH THE PROCEDURE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. OUR EVALUATION OF THE RETURNED DEVICE ON 3/8/2022 DETERMINED THAT THE DISTAL TIP OF THE CATHETER IS CRACKED, IT IS ALSO JAGGED AND A PIECE OF THE CATHETER IS PROTRUDING OUT [SUBJECT OF REPORT]. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1913851 FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS COOK ENDOSCOPY G55815 W4539113 00827002558151

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown