BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC

    MDR report key: 23728114 · Received December 5, 2025

    Report

    Report Number
    1037905-2025-00816
    Event Type
    Malfunction
    Date Received
    December 5, 2025
    Date of Event
    October 31, 2025
    Report Date
    December 5, 2025
    Manufacturer
    WILSON-COOK MEDICAL INC (COOK ENDOSCOPY)
    Product Code
    KNQ
    UDI-DI
    00827002517950
    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 POUCH FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABEL MATCHES THE PRODUCT RETURNED. PHOTOS WERE PROVIDED AND REVIEWED. ONE PHOTO SHOWS A PORTION OF THE DEVICE, AND THERE IS A BREAK IN THE CATHETER. THE ADDITIONAL PHOTO SHOWS THE POUCH, AND THE LOT NUMBER MATCHES THE REPORT. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. THE BALLOON WAS RETURNED AND APPEARED TO NOT HAVE BEEN INFLATED. DURING A VISUAL EXAMINATION, A BREAK IN THE OUTER BLUE CATHETER WAS IDENTIFIED APPROXIMATELY 68 CM FROM THE DISTAL END OF THE WHITE STRAIN RELIEF, EXPOSING THE INNER PURPLE CATHETER. WE WERE UNABLE TO DETERMINE THE CAUSE OF THE DAMAGE TO 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 WITH STEM BUMPER WAS 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 EVALUATION OF THE RETURNED DEVICE CONFIRMED THE REPORT. A CORRECTIVE ACTION (CAPA) HAS BEEN INITIATED TO REDUCE OCCURRENCES OF CATHETER CRACKING, SPLITTING OR BREAKING FOR HBD-W DEVICES. THE PRODUCT SAID TO BE INVOLVED IS INCLUDED IN THE SCOPE OF THE CORRECTIVE ACTIONS. IN THE ADDITIONAL INFORMATION PROVIDED, THE USER STATED THAT NEGATIVE PRESSURE WAS NOT APPLIED TO THE BALLOON PRIOR TO ADVANCEMENT THROUGH THE ENDOSCOPE. 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 LEAK TEST 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 CORRECTIVE ACTION (CAPA) HAS BEEN INITIATED IN AN EFFORT TO REDUCE OCCURRENCES OF THIS NATURE. THIS PRODUCT WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF THIS CORRECTIVE ACTION. A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS. ADDITIONAL COMMENTS: BASED ON THE INFORMATION PROVIDED THAT NEGATIVE PRESSURE WAS NOT APPLIED TO THE BALLOON PRIOR TO ADVANCEMENT THROUGH THE ENDOSCOPE, 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 AN ENDOSCOPIC PROCEDURE FOR BILE DUCT STONE REMOVAL, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. IT WAS REPORTED [THAT] THE USER ADVANCED THE DEVICE THROUGH THE ENDOSCOPIC WORKING CHANNEL [AND] FOUND OUT THE SHEATH CRACKED. USER TRIED TO DILATE THE DEVICE BUT COULD NOT REACH DESIRED RESULT. USER CHANGED TO A NEW DEVICE TO COMPLETE THE PROCEDURE. 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
    2782882 HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC DILATOR, ESOPHAGEAL KNQ WILSON-COOK MEDICAL INC (COOK ENDOSCOPY) G51795 W4933604 00827002517950

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male OLYMPUS ENDOSCOPE, UNKNOWN MODEL