MAUDE Adverse Event Report: WELL LEAD MEDICAL CO., LTD URETERAL ACCESS SHEATH, 11-13 FR X 50CM

Model Number	XUSM0093
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Perforation (2001); Rupture (2208)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the ureteral access sheath used was not a karl storz product.We have informed (b)(4) of this incident as they are the manufacturer for the ureteral access sheath.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that one of the sheath did cause injury to the patients ureter and ended up perforating it and it could be that the surgeons tried to push too hard into the kidney and it could have been the reason for the tear.A further evaluation cannot be conducted as karl storz is not the legal manufacturer of the device.The karl storz team did notify the third party distributor (b)(4) of the event report required on april 1,2025.

• Brand Name: URETERAL ACCESS SHEATH, 11-13 FR X 50CM
• Common Device Name: URETERAL ACCESS SHEATH, 11-13 FR X 50CM
• Manufacturer (Section D): WELL LEAD MEDICAL CO., LTD; c-4#jinhu industrial estate; hualong, panyu guangzhou 51143 4; CH 511434
• MDR Report Key: 21861810
• Report Number: 2020550-2025-00654
• Device Sequence Number: 4695925
• Product Code: FED
• UDI-Device Identifier: 06936881196270
• UDI-Public: 06936881196270
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/17/2025
• Report Date (Section F): 04/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: XUSM0093
• Device Catalogue Number: XUSM0093
• Device Lot Number: 08022717BG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/31/2025
• Event Location: Hospital
• Date Report to Manufacturer: 04/01/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/17/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown