MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION VIRTUOSAPH PLUS WITH RADIAL INDICATION; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number VSP550EX

Device Problem Temperature Problem (3022)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 12/16/2022

Event Type  malfunction  

Event Description

Narrative from staff: redacted date, the patient has endoscopic vessel harvesting of the saphenous vein on the left leg for coronary artery bypass graft.The patient was burned by the light source that was used.The burn was superficial and bacitracin ointment was applied to it.

• Brand Name: VIRTUOSAPH PLUS WITH RADIAL INDICATION
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 16130180
• MDR Text Key: 307012050
• Report Number: 16130180
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VSP550EX
• Device Catalogue Number: VSP550EX
• Device Lot Number: 24K
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/22/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 23360 DA
• Patient Sex: Male
• Patient Weight: 88 KG