BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC

    MDR report key: 23597025 · Received November 19, 2025

    Report

    Report Number
    1037905-2025-00787
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    November 3, 2025
    Report Date
    November 19, 2025
    Manufacturer
    WILSON-COOK MEDICAL INC (COOK ENDOSCOPY)
    Product Code
    KNQ
    UDI-DI
    00827002517967
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1 - PHONE: (B)(6). INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS PERFORMED ONLY BY THE PICTURES PROVIDED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE LOT NUMBER IN THE PHOTO PROVIDED MATCHES THE REPORT. A REVIEW OF THE PHOTOS PROVIDED CONFIRMED THE REPORT. THE CATHETER IS BROKEN IN THE SILVER PRINT MARKING AREA AT THE DISTAL END OF THE DEVICE, NEAR THE BALLOON. THE INNER PURPLE CATHETER IS ALSO EXPOSED IN THE AREA OF THE BREAK. NO OTHER DETAILS OR ABNORMALITIES CAN BE DETERMINED FROM THE PHOTOS RECEIVED. 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 PHOTOS PROVIDED CONFIRMED THE REPORT. THE INFORMATION PROVIDED INDICATED THAT THE BALLOON WAS ADVANCED DIRECTLY INTO THE PATIENT WITHOUT USING AN ENDOSCOPE. THIS IS AGAINST THE INSTRUCTIONS FOR USE OF THE DEVICE AND THE MOST LIKELY CAUSE FOR THE REPORTED OBSERVATION. THE INSTRUCTIONS FOR USE STATE: "MAINTAIN BALLOON DEFLATION WITH NEGATIVE PRESSURE AND INTRODUCE INTO THE ACCESSORY CHANNEL OF THE ENDOSCOPE, ADVANCING IN SHORT INCREMENTS UNTIL THE DILATOR IS COMPLETELY VISUALIZED ENDOSCOPICALLY." PRIOR TO DISTRIBUTION, ALL HERCULES 3 STAGE WIREGUIDED BALLOONS ESOPHAGEAL-PYLORIC-COLONIC ARE SUBJECTED TO A VISUAL EXAMINATION 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. THERE HAVE BEEN NO OTHER SIMILAR OCCURRENCES REPORTED DURING THE TIME PERIOD REVIEWED. THEREFORE, THIS REPORT REPRESENTS AN ISOLATED OCCURRENCE. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS REMOTE. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS. ADDITIONAL COMMENTS: BASED ON THE INFORMATION PROVIDED THAT THE DEVICE WAS USED WITHOUT AN 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 UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. IT WAS REPORTED THAT THE BALLOON CATHETER BROKE WHEN INTRODUCED. WATER WAS LEAKING AT THE PROXIMAL END OF THE BALLOON THE MOMENT THEY INSUFFLATED WATER. IMAGE OF BROKEN CATHETER 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
    2361968 HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC DILATOR, ESOPHAGEAL KNQ WILSON-COOK MEDICAL INC (COOK ENDOSCOPY) G51796 W4956089 00827002517967

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN ENDOSCOPE MAKE AND MODEL.