MAUDE Adverse Event Report: Terumo Cardiovascular Systems Corporation Virtuosaph Plus with Radial Indication; Electrosurgical, Cutting Coagulation Accessories

Model Number	VSP550EX
Medical Device Problem Codes	Gas/Air Leak (2946); Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Co2 gas leak/ would not maintain pressure.

• Brand Name: Virtuosaph Plus with Radial Indication
• Common Device Name: Electrosurgical, Cutting Coagulation Accessories
• Manufacturer (Section D): Terumo Cardiovascular Systems Corporation; 125 blue ball rd; elkton MD 21921
• MDR Report Key: 50053490
• Report Number: 50053490
• Device Sequence Number: 9462345
• Product Code: GEI
• UDI-Device Identifier: 00699753450769
• UDI-Public: (01)00699753450769
• 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: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/20/2026
• Report Date (Section F): 07/20/2026

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: VSP550EX
• Device Lot Number: 5ZKI
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/28/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/28/2026
• 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
• Patient Weight: 216 LB
• Date Report Sent to FDA: 07/20/2026