MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC (COOK ENDOSCOPY) HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC; DILATOR, ESOPHAGEAL

Model Number	G51797
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: the product said to be involved was returned in a clear plastic bag.Provided with the return was an open pouch from the lot number provided in the report.The label matches the product returned.Our laboratory evaluation of the product said to be involved confirmed the report.The balloon was returned deflated.During a visual examination, a kink in the outer blue catheter was identified approximately 120.1 cm from the distal end of the white strain relief.The catheter was also broken approximately 117 cm from the distal end of the white strain relief, exposing the inner purple catheter.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.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 complaint.In the report it states that the balloon was inflated with air.The ifu states ¿this balloon is used in conjunction with an inflation device or manometer and may be filled with sterile water, sterile saline or up to a 1:1 contrast medium mixture consisting of contrast and sterile saline." this is the most likely cause of the report.Additionally, the report states that lubrication was not applied to the balloon prior to advancing down the endoscope accessory channel.Applying lubrication will aid in balloon preservation and optimize balloon performance.The instructions for use direct the user to "apply a lubricating agent to the balloon to facilitate passage through the endoscope accessory channel".This activity will aid in endoscopic advancement and balloon preservation.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 balloon was inflated with air, 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.
Event or Problem Description
During a pyloric dilation procedure, the physician used a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic.It was reported that the user put the balloon into the scope and it was so difficult to remove from the endoscope that they damaged the balloon while pulling it out.They had to remove the endoscope from the patient and then re-entered the endoscope to finish 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.

• Brand Name: HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): WILSON-COOK MEDICAL INC (COOK ENDOSCOPY); 4900 bethania station rd; winston salem NC 27105
• Manufacturer (Section G): WILSON-COOK MEDICAL INC (COOK ENDOSCOPY); 4900 bethania station rd; winston salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston salem, NC 27105 ; 3367440157
• MDR Report Key: 25683505
• Report Number: 1037905-2026-00315
• Device Sequence Number: 9731467
• Product Code: KNQ
• UDI-Device Identifier: 00827002517974
• UDI-Public: (01)00827002517974(17)290406(10)W5021299
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G51797
• Device Catalogue Number: HBD-W-15-16.5-18
• Device Lot Number: W5021299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN ENDOSCOPE MAKE AND MODEL
• Patient Sex: Unknown