MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC CONQUEST TTC LITHOTRIPTOR CABLE WITH ADAPTER; LITHOTRIPTER, BILIARY MECHANICAL

Model Number	G25472
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During lithotripsy, the physician used a cook conquest ttc lithotriptor cable with adapter.It was reported that when the physician inserted this product into the patient, it could not be withdrawn.Significant force was ultimately required to remove it.Subsequently, the product showed severe visible twisting.The procedure was completed with a new same device.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: the product said to be involved was returned in a clear plastic bag.A lot number was not provided with the returned device.A photo of the device coiled within an unlabeled pouch was provided.The shrink tubing can be seen to have buckled and the proximal hub has moved distal to the intended location.Our evaluation of the product said to be involved confirmed the report.The proximal hub has moved distally relative to the intended location.The shrink tube has peeled and buckled at the proximal end due to the shifting of the proximal hub.The coil spring extended from the proximal end approximately 6.3cm from the hub with no shrink tubing remaining on the section.The coil spring has been misshapen approximately 6mm from the proximal tip of the coil spring.Evidence of solder was noted at the deformed location, indicative of the solder joint which would be intended to have secure the hub in place on the coil spring.The shrink tubing at the distal end of the hub was cut and peeled to exposed the distal end of the hub.A broken and detached piece of solder was found within the shrink tubing, indicating that the solder was present, but that the joint had broken.Evidence of solder was noted on the distal end of the hub.The proximal hub has become fixed on the coil spring and was not able to be pulled proximally to it's originally intended position.A product discrepancy or anomaly that could have contributed to this reported occurrence was not observed.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.The proximal adapter/hub has shifted distally with buckling of the shrink tubing.A definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.Prior to distribution, all conquest ttc lithotriptor cable with adapters 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.

• Brand Name: CONQUEST TTC LITHOTRIPTOR CABLE WITH ADAPTER
• Common Device Name: LITHOTRIPTER, BILIARY MECHANICAL
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC ; 3367440157
• MDR Report Key: 24053777
• Report Number: 1037905-2026-00024
• Device Sequence Number: 9883616
• Product Code: LQC
• UDI-Device Identifier: 00827002254725
• UDI-Public: (01)00827002254725(17)270118(10)W4803257
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/13/2026

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: G25472
• Device Catalogue Number: TTCL-1
• Device Lot Number: W4803257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2024
• 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: OLYMPUS JF_260 SCOPE.
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 54 KG