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

Model Number	G51795
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: a product evaluation was performed only by the pictures provided with this report because the product said to be involved was not provided to cook for evaluation.A photo of the lot number was not provided.Our evaluation of the photos provided confirmed the report.The photos show the distal end of the device, and there is a rupture/split in the balloon material.The rupture/split appears to be from the distal to proximal end of the balloon.Per the photos provided we cannot complete a full evaluation.Without the product or substantial evidence to contradict the complaint, it is considered confirmed based solely on statements and photos describing the event.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.However, 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.In the report it states that negative pressure and lubrication were not applied to the balloon prior to advancing down the endoscope accessory channel.Negative pressure and applying lubrication will aid in balloon preservation and optimize balloon performance.Negative pressure and applying lubrication 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.A leakage/damage to the balloon material can 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 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 negative pressure and lubrication were 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.
Event or Problem Description
During an esophageal dilation, the physician used a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic.It was reported that the dilation balloon ruptured [leakage], making it impossible to inflate balloon.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: 24004060
• Report Number: 1037905-2026-00016
• Device Sequence Number: 10222248
• Product Code: KNQ
• UDI-Device Identifier: 00827002517950
• UDI-Public: (01)00827002517950(17)280417(10)W4931454
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K090183
• Number of Events Summarized: 1
• Summary Report (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): 01/08/2026

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: G51795
• Device Catalogue Number: HBD-W-10-11-12
• Device Lot Number: W4931454
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2025
• 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: BOSTON PRESSURE GAUGE [INFLATION DEVICE]; UNKNOWN ENDOSCOPE MAKE AND MODEL
• Patient Sex: Female