MAUDE Adverse Event Report: URO-1, INC. SUREcore Plus Biopsy Instrument; Instrument, Biopsy

Model Number	SP-LA18-25
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Disposable biopsy core needle was noted to be bent after use on the patient.

• Brand Name: SUREcore Plus Biopsy Instrument
• Common Device Name: Instrument, Biopsy
• Manufacturer (Section D): URO-1, INC.; 3703 alliance drive; suite a; greensboro NC 27407
• MDR Report Key: 50927400
• Report Number: 50927400
• Device Sequence Number: 9509314
• Product Code: KNW
• UDI-Device Identifier: 00860014338663
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/05/2026
• Report Date (Section F): 09/05/2026

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: SP-LA18-25
• Device Catalogue Number: SP-LA18-25
• Device Lot Number: 4002-A-27
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/29/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Date Report Sent to FDA: 09/05/2026