MAUDE Adverse Event Report: CMR Surgical Limited Versius Surgical System; Versius Camera Head

Catalog Number	90911
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2026
Type of Reportable Event	Malfunction

• Brand Name: Versius Surgical System
• Common Device Name: Versius Camera Head
• Manufacturer (Section D): CMR Surgical Limited; 1 evolution business park; milton road; cambridge, CB24 9NG; UK CB24 9NG
• Manufacturer (Section G): CMR Surgical Limited; 207 lancaster way; ely, CB6 3 NX; UK CB6 3NX
• Manufacturer Contact: agnieszka nowacka-perrin ; 1 evolution business park; milton road; cambridge, CB24 -9NG ; UK CB24 9NG
• MDR Report Key: 50274491
• Report Number: 3015488559-2026-00171
• Device Sequence Number: 10578487
• Product Code: SCV
• UDI-Device Identifier: 05060548210748
• UDI-Public: (01)05060548210748
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2026

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 Catalogue Number: 90911
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2026
• Initial Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown