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	09/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was alleged that the cable connector was found damaged during surgery setup.The exact cause of the damage could not be determined, as no specific event leading to the failure was identified.However, this type of connector damage is typically associated with excessive or misaligned force during connection or disconnection and is therefore considered most likely to be handling-related.As spare camera head was used and the procedure was successfully complete with the use of versius surgical system.The camera cable was subsequently replaced.No harm was reported in relation to this event.At the time of this report, no further information has been provided.
Additional Manufacturer Narrative
Cmr surgical limited is submitting this report to comply with fda regulation 803.The device was inspected by the distributor.Mechanical damage was found, which was probably due to improper handling during connection and removal of the cable.Cmr surgical ltd does not consider this report and content to be an admission that its product is defective or that it has caused a death or serious injury.

• 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: 50896103
• Report Number: 3015488559-2026-00244
• Device Sequence Number: 10705665
• Product Code: SCV
• UDI-Device Identifier: 05060548210748
• UDI-Public: (01)05060548210748
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: 09/11/2026
• Initial Report FDA Received Date: 09/25/2026
• 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