MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC SOEHENDRA LITHOTRIPTOR HANDLE; LITHOTRIPTOR, BILIARY, MECHANICAL

Model Number	G21860
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During an endoscopic procedure, the physician used a cook soehendra lithotriptor handle.It was reported that the customer was using the device, outside of the intended use.The device was used to remove an eroded, adjustable, gastric band.During this attempt to remove the band the handle broke.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 cardboard box.A lot number was not provided with the returned device.A photo of the device was provided and reviewed.The photo shows that the center bar has broken in the middle with the rotational handle separating with the detached half of the center bar.The ratchet mechanism's wire has become bent and misshapen.A photo of the lot number was not provided.Our laboratory evaluation of the product said to be involved confirmed the report.The center bar has broken in the middle with the rotational handle separating with the detached half of the center bar.Under magnification striations were present around the circumference of the center bar, indicating something was likely wrapped around and tensioned.The ratchet mechanism's wire has become bent and misshapen.When rotating the remaining attached center bar the ratchet mechanism, while damaged, maintains some functionality as it only allows rotation in one direction.The fixed handle remains attached but has become slightly bent.No portion of the device was found to be missing.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 of handle breakage.The description of event indicates that this occurred during removal of a gastric band.This is against the intended use for this device.The instructions for use state: "this device is used to mechanically crush stones in the biliary duct when other methods of endoscopic removal have failed." use of the device outside of the intended use is the likely root cause for the reported occurrence.Prior to distribution, all soehendra lithotriptor handles 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.There have been no other similar occurrences reported during the time period reviewed.Therefore, this report represents an isolated occurrence.Quality assurance will continue to monitor for complaint trends.Additional comments: based on the information provided that this occurred during removal of a gastric band.This is against the intended use for this device and 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: SOEHENDRA LITHOTRIPTOR HANDLE
• Common Device Name: LITHOTRIPTOR, BILIARY, MECHANICAL
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC
• Manufacturer (Section G): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston salem
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston salem, NC ; 3367440157
• MDR Report Key: 24593677
• Report Number: 1037905-2026-00127
• Device Sequence Number: 18500545
• Product Code: LQC
• UDI-Device Identifier: 00827002218604
• UDI-Public: (01)00827002218604(17)270212(10)W4810689
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2026

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: G21860
• Device Catalogue Number: SLH-1
• Device Lot Number: W4810689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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: SCOPE, UNKNOWN MAKE AND MODEL
• Patient Sex: Unknown