MAUDE Adverse Event Report: Wilson-Cook Medical Inc (Cook Endoscopy) HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC; Dilator, Esophageal

Model Number	G51796
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During a tracheal stenosis dilation procedure, the physician used a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic.It was reported "[that]" a balloon leak was observed in the catheter, requiring a replacement during 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.
Additional Manufacturer Narrative
Investigation evaluation: a product evaluation was performed only by the picture provided with this report because the product said to be involved was not provided to cook for evaluation.A picture of the lot number was not provided.Our evaluation of the picture provided confirmed the report.The picture shows the device in a coiled position within a clear plastic bag, and the catheter appears to be broken.Based on the picture provided we were unable to determine the location of the break in the catheter.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 picture provided confirmed the report.There were several use related factors that likely contributed to the reported device failure, use outside the intended use, inflated with air, and used without negative pressure.Specifically, in the report it states that the device was used to dilate the trachea.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." the customer also indicated 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." additional information provided also indicated 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 balloon was inflated with air and negative pressure was not applied to the balloon prior to advancing down the endoscope accessory channel, 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.

• 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 ; +1(336)744-0157
• MDR Report Key: 50883444
• Report Number: 1037905-2026-00582
• Device Sequence Number: 10664237
• Product Code: KNQ
• UDI-Device Identifier: 00827002517967
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: G51796
• Device Catalogue Number: HBD-W-12-13.5-15
• Device Lot Number: W5002757
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: Unknown Endoscope Make and Model
• Patient Sex: Unknown