BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE

    MDR report key: 11893575 · Received May 27, 2021

    Report

    Report Number
    1037905-2021-00223
    Event Type
    Malfunction
    Date Received
    May 27, 2021
    Date of Event
    May 5, 2021
    Report Date
    July 2, 2021
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNS
    UDI-DI
    10827002346014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION G 4, PMA/510(K) #: K172288. INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. THERE IS WIRE GUIDE COATING DAMAGE NEAR THE DISTAL END. A SECTION OF CORE WIRE WAS EXPOSED FROM APPROXIMATELY 6.8CM TO 27.3CM FROM THE DISTAL END. AN ADDITIONAL SECTION OF COATING ALSO RETURNED AND MEASURED 17.1CM IN LENGTH. DUE TO THE CONDITION OF THE RETURNED DEVICE IT CANNOT BE DETERMINED IF ANY SECTIONS OF THE COATING ARE MISSING. APPROXIMATELY 2.3CM TO 6.8CM FROM THE DISTAL END, THE WIRE GUIDE COVERING HAS FOLDED OVER ITSELF. APPROXIMATELY 2.3CM TO 3.2CM FROM THE DISTAL END, THE WIRE GUIDE COVERING HAS TWICE FOLDED OVER. A PRODUCT-SPECIFIC DISCREPANCY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS. THE DEVICE HISTORY RECORDS FOR THE SPHINCTEROTOME AND WIRE GUIDE LOTS WERE REVIEWED. THE DEVICE HISTORY RECORDS CONTAIN NONCONFORMANCES THAT COULD POTENTIALLY BE RELATED TO WIRE GUIDE DAMAGE. THE DEVICE GOES THROUGH DIFFERENT INSPECTIONS PRIOR TO LEAVING THE FACILITY. THESE INSPECTIONS WOULD HAVE REMOVED ANY NONCONFORMING DEVICES PRIOR TO DISTRIBUTION. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSION: A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PATIENT ANATOMY, ENDOSCOPE POSITION OR PROGRESSION OF DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LABORATORY ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. 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. PRIOR TO DISTRIBUTION, ALL FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDES ARE SUBJECTED TO A VISUAL INSPECTION 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: 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.

    Additional Manufacturer Narrative · 1

    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 RECORDS FOR THE SPHINCTEROTOME AND WIRE GUIDE LOTS WERE REVIEWED. THE DEVICE HISTORY RECORDS CONTAIN NONCONFORMANCE'S THAT COULD POTENTIALLY BE RELATED TO WIRE GUIDE DAMAGE. THE DEVICE GOES THROUGH DIFFERENT INSPECTIONS PRIOR TO LEAVING THE FACILITY. THESE INSPECTIONS WOULD HAVE REMOVED ANY NONCONFORMING DEVICES PRIOR TO DISTRIBUTION. 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. 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. PRIOR TO DISTRIBUTION, ALL FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDES ARE SUBJECTED TO A VISUAL INSPECTION 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: 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 · 1

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE AND STATED THAT ON PLACING A 7F PIGTAIL STENT, ON REMOVAL OF THE WIRE TO DEPLOY THE STENT, A BLACK STRIP WAS SEEN IN THE LUMEN OF THE STENT WHICH WAS REMOVED WITH FORCEPS. THIS WAS APPROXIMATELY 10 INCHES OF THE WIRE COATING PRIOR TO THE FLEXIBLE WIRE TIP. A SECTION OF THE DEVICE DID 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
    794553 FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS COOK ENDOSCOPY G34601 W4434594 10827002346014

    Patients

    Seq Age Sex Outcome Treatment
    1