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 Codes	Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continued e1: phone number: (b)(6).Investigation evaluation: a product evaluation was performed only by the picture provided in response to 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 a portion of the device inside the pouch, and the balloon has been removed/cut from the distal end of the device.The proximal portion of the balloon appears to be ruptured/split, confirming the complaint.Without the product or substantial evidence to contradict the complaint, it is considered confirmed based solely on statements and photo 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 picture 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 does not state if negative pressure and/or lubrication was applied to the balloon prior to advancement through the endoscope.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 "apply a lubricating agent to the balloon to facilitate passage through the endoscope accessory channel" and 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.
Event or Problem Description
During an endoscopic dilation, the physician used a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic.It was reported that during the beginning of balloon inflation, the liquid began to leak through the catheter, making it necessary to open another balloon to complete 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 in response to 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 a portion of the device inside the pouch, and the balloon has been removed/cut from the distal end of the device.The proximal portion of the balloon appears to be ruptured/split, confirming the complaint.Without the product or substantial evidence to contradict the complaint, it is considered confirmed based solely on statements and photo 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 picture 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 the balloon was tested prior to use.The ifu states: "do not pre-inflate the balloon." this is the most likely cause of the report.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 tested prior to use, 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
• MDR Report Key: 23407765
• Report Number: 1037905-2025-00736
• Device Sequence Number: 8890887
• Product Code: KNQ
• UDI-Device Identifier: 00827002517974
• UDI-Public: (01)00827002517974(17)261120(10)W4785788
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2025

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: G51797
• Device Catalogue Number: HBD-W-15-16.5-18
• Device Lot Number: W4785788
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/20/2023
• 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: FUJI 720 SCOPE
• Patient Age: 77 YR
• Patient Sex: Female