BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE

    MDR report key: 18320847 · Received December 13, 2023

    Report

    Report Number
    1037905-2023-00618
    Event Type
    Malfunction
    Date Received
    December 13, 2023
    Report Date
    December 13, 2023
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. 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. HOWEVER, THE CUSTOMER'S DESCRIPTION OF THE EVENT STATES THE COATING "WIRE SHREDS AND PEELS ON THE SCOPE ELEVATOR". IF ADDITIONAL PRESSURE IS APPLIED TO THE WIRE GUIDE AND/OR ACCESSORY DEVICE(S) WHILE MOVING THE WIRE GUIDE INSIDE THE ACCESSORY DEVICE(S), THIS COULD CONTRIBUTE TO WIRE GUIDE COATING DAMAGE. EXCESSIVE PRESSURE APPLIED BY THE ELEVATOR IS A POTENTIAL CAUSE FOR COATING DAMAGE. PRIOR TO DISTRIBUTION, ALL FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDES ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: 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 MULTIPLE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURES, THE PHYSICIAN USED COOK FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDES. IT WAS REPORTED THAT THE HC [HYDROPHILIC] COATING OF THE WIRE [GUIDES] SHRED AND PEELS ON THE SCOPE ELEVATOR. THEREFORE, A NEW DEVICE HAS TO BE OPENED EACH TIME TO COMPLETE THE INTENDED PROCEDURES SUCCESSFULLY. 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
    244990 FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS WILSON-COOK MEDICAL INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown COOK ACRO-35-260 WIRE GUIDE.| OLYMPUS ENDOSCOPE, UNKNOWN MODEL.