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	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: the product said to be involved was returned in a white plastic bag.Provided with the return was an open pouch from the lot number provided in the report.The label matches the product returned.Photos were provided and reviewed.One photo shows a portion of the device, and there is a break in the catheter.The additional photo shows the pouch, and the lot number matches the report.Our laboratory evaluation of the product said to be involved confirmed the report.The balloon was returned and appeared to not have been inflated.During a visual examination, a break in the outer blue catheter was identified approximately 68 cm from the distal end of the white strain relief, exposing the inner purple catheter.We were unable to determine the cause of the damage to the catheter.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.Note: the pre-loaded wire guide with stem bumper was not included in the return.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 report.A corrective action (capa) has been initiated to reduce occurrences of catheter cracking, splitting or breaking for hbd-w devices.The product said to be involved is included in the scope of the corrective actions.In the additional information provided, the user stated that negative pressure was not applied to the balloon prior to advancement through the endoscope.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 leak test 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: a corrective action (capa) has been initiated in an effort to reduce occurrences of this nature.This product was manufactured prior to implementation of this corrective action.A review of the complaint history was conducted.Quality assurance will continue to monitor for complaint trends.Additional comments: based on the information provided that negative pressure was 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 endoscopic procedure for bile duct stone removal, the physician used a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic.It was reported [that] the user advanced the device through the endoscopic working channel [and] found out the sheath cracked.User tried to dilate the device but could not reach desired result.User changed to a new device 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.

• 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: 23728114
• Report Number: 1037905-2025-00816
• Device Sequence Number: 10216228
• Product Code: KNQ
• UDI-Device Identifier: 00827002517950
• UDI-Public: (01)00827002517950(17)280424(10)W4933604
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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): 12/05/2025

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: G51795
• Device Catalogue Number: HBD-W-10-11-12
• Device Lot Number: W4933604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2025
• 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: OLYMPUS ENDOSCOPE, UNKNOWN MODEL
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 68 KG