MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC HERCULES 3 STAGE BALLOON ESOPHAGEAL; DILATOR, ESOPHAGEAL

Model Number	G31926
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 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: 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.The additional information provided states that it is unknown if the user applied lubrication to the balloon prior to advancement through the endoscope accessory channel.A possible contributing factor to a leakage is failure to apply lubrication to the balloon prior to advancement.The instructions for use advise the user with the following: "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.A leakage can also occur if the balloon comes into contact with a sharp object or a burr in the endoscope channel.Another possible contributing factor to a leakage in the balloon material is using a compromised inflation device to inflate the balloon.If the pressure reading of the inflation device is inaccurate, this could contribute to over inflation, possibly resulting in damage to the balloon material.Prior to distribution, all hercules 3 stage balloons esophageal 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.
Event or Problem Description
During an esophageal endoscopic procedure, the physician used a cook hercules 3 stage balloon esophageal.It was reported [that] once in the patient, the balloon had a leak and would [not] inflate.The procedure was successfully completed with another device of the same type.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 BALLOON ESOPHAGEAL
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 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: 22793601
• Report Number: 1037905-2025-00587
• Device Sequence Number: 20899068
• Product Code: KNQ
• UDI-Device Identifier: 00827002319264
• UDI-Public: (01)00827002319264(17)280425(10)W4933823
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2025

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: G31926
• Device Catalogue Number: HBD-12-13.5-15
• Device Lot Number: W4933823
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 08/13/2025
• Date Device Manufactured: 04/25/2025
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COOK DS 60 CC DILATION SYRINGE; OLYMPUS 190 ENDOSCOPE
• Patient Sex: Unknown