BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC

    MDR report key: 23480075 · Received November 5, 2025

    Report

    Report Number
    1037905-2025-00751
    Event Type
    Malfunction
    Date Received
    November 5, 2025
    Date of Event
    October 9, 2025
    Report Date
    November 5, 2025
    Manufacturer
    WILSON-COOK MEDICAL INC (COOK ENDOSCOPY)
    Product Code
    KNQ
    UDI-DI
    00827002517998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN A WHITE PLASTIC BAG. PROVIDED WITH THE RETURN WAS AN OPEN BOX FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABEL MATCHES THE PRODUCT RETURNED. PHOTOS WERE PROVIDED AND REVIEWED. THE LOT NUMBER IN THE PHOTOS MATCHES THE REPORT. THE SECOND PHOTO SHOWS THE DEVICE IN A COILED POSITION, AND THE BALLOON APPEARS TO BE DEFLATED. NO DAMAGE TO THE CATHETER OR BALLOON CAN BE SEEN IN THE PHOTO. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT DUE TO A PINHOLE IN THE BALLOON MATERIAL. THE DEVICE WAS RETURNED WITH THE BALLOON DEFLATED. DURING FUNCTIONAL TESTING A COOK DILATION SYRINGE (DS-60CC-S) WAS FILLED WITH WATER AND ATTACHED TO THE BALLOON INFLATION PORT. THE SYRINGE WAS PLACED INTO AN INFLATION HANDLE, AND NEGATIVE PRESSURE WAS APPLIED TO THE BALLOON. AFTER APPLYING NEGATIVE PRESSURE, THE BALLOON WAS ATTEMPTED TO BE INFLATED. THE BALLOON WOULD NOT FULLY INFLATE OR HOLD PRESSURE, AND LEAKAGE WAS OBSERVED FROM A PINHOLE IN THE PROXIMAL AREA OF THE BALLOON MATERIAL, CONFIRMING THE COMPLAINT. DURING A VISUAL EXAMINATION, A KINK WAS ALSO OBSERVED IN THE IN THE SILVER PRINTED AREA OF THE CATHETER. A PRODUCT-SPECIFIC DISCREPANCY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS NOTE: THE PRE-LOADED WIRE GUIDE AND STEM BUMPER ASSOCIATED WITH THIS DEVICE WERE NOT INCLUDED IN THE RETURN. 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: OUR LABORATORY EVALUATION OF THE RETURNED DEVICE CONFIRMED THE REPORT DUE TO A PINHOLE IN THE BALLOON MATERIAL. IN THE REPORT IT STATES THAT THE BALLOON WAS USED IN THE BILIARY SYSTEM TO DILATE THE BILE DUCT. THIS IS OUTSIDE OF THE STATED INTENDED USE AND THE MOST LIKELY CAUSE OF THE REPORT. THE IFU STATES, "THIS DEVICE IS USED TO DILATE STRICTURES OF THE GASTROINTESTINAL TRACT, INCLUDING STRICTURES OF THE ESOPHAGUS, PYLORUS, DUODENUM, AND COLON." IN THE REPORT IT ALSO STATES THAT NEGATIVE PRESSURE WAS NOT APPLIED TO THE BALLOON PRIOR TO ADVANCING DOWN THE ENDOSCOPE ACCESSORY CHANNEL. NEGATIVE PRESSURE WILL AID IN BALLOON PRESERVATION AND OPTIMIZE BALLOON PERFORMANCE. THE INSTRUCTIONS FOR USE DIRECT THE USER "TO FACILITATE PASSAGE THROUGH THE ENDOSCOPE, APPLY NEGATIVE PRESSURE TO THE DEVICE." IN ADDITION, THE USER IS FURTHER INSTRUCTED TO "MAINTAIN BALLOON DEFLATION WITH NEGATIVE PRESSURE AND INTRODUCE INTO ENDOSCOPE ACCESSORY CHANNEL, ADVANCING IN SHORT INCREMENTS UNTIL BALLOON IS COMPLETELY VISUALIZED ENDOSCOPICALLY." THE APPLICATION OF NEGATIVE PRESSURE WILL ASPIRATE ALL RESIDUAL AIR FROM THE BALLOON AND EASE ENDOSCOPIC ADVANCEMENT. PRIOR TO DISTRIBUTION, ALL HERCULES 3 STAGE WIRE GUIDED BALLOONS ESOPHAGEAL-PYLORIC-COLONIC 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. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS RARE. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS. ADDITIONAL COMMENTS: BASED ON THE INFORMATION PROVIDED THAT THE DEVICE WAS USED TO DILATE THE BILE DUCT FOR STONE REMOVAL AND NEGATIVE PRESSURE WAS NOT APPLIED, A COOK REPRESENTATIVE HAS BEEN DIRECTED TO CONTACT THE MEDICAL FACILITY INVOLVED IN AN EFFORT TO PROMOTE FURTHER EDUCATION AND UNDERSTANDING RELATED TO APPROPRIATE USAGE OF THIS PRODUCT.

    Description of Event or Problem · 0

    DURING A STONE REMOVE PROCEDURE IN THE BILE DUCT, THE USER SELECTED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. IT WAS REPORTED [THAT] USER ADVANCED THE BALLOON DEVICE THROUGH ENDOSCOPE WORKING CHANNEL TO STENOSIS AREA TO DILATE WHILE FINDING OUT THE LEAKING ISSUE. USER CHANGED TO ANOTHER DEVICE TO CONTINUE THE PROCEDURE. AN IMAGE OF THE DEVICE SHOWING THE BALLOON DEFLATED WAS PROVIDED. 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
    2606355 HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC DILATOR, ESOPHAGEAL KNQ WILSON-COOK MEDICAL INC (COOK ENDOSCOPY) G51799 W4950153 00827002517998

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female SONOSCAPE, UNKNOWN MODEL