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

Model Number	VSP550EX
Medical Device Problem Codes	Melted (1385); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Terumo has not received the device for evaluation; therefore, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.For this reason, terumo references evaluation conclusion code 11.D4: primary unique device identification (udi) number is only the di number.The pi number is not available as the lot number is unknown.
Event or Problem Description
The user facility reported to terumo cardiovascular that during vein harvesting, the tip was melted.The harvester smelled burning plastic and saw smoke on screen when using the yellow (cut) foot pedal during the saphenous vein harvest using virtuosaph plus (vsp).The foot pedal was used twice and it did not seem right, so the device was pulled it out of the leg and examined.The foot pedal (cut-yellow) was hit once more in the air and saw the smoke and melting at a small section below the grounding pads on the device.No consequence or health impact to patient.Product was changed out.Procedure was completed successfully.
Additional Manufacturer Narrative
This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on october 30, 2025.Upon further investigation of the reported event, the following information is new and/or changed: b5 (added describe event or problem), d9 (updated device not available for evaluation), g3 (date received by manufacturer) , g6 (indication that this is a follow-up report), h2 (follow-up due to additional information).A second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references conclusions code 11.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
Event or Problem Description
Additional information was received from the user facility: brand of generator was used is olympus esg 400.The generator settings were 8 cut / 12 coagulation, both on effect 3.The settings were not modified during the case.
Additional Manufacturer Narrative
This follow-up report is submitted to fda in accord with applicable regulations.Upon further investigation of the reported event, the following information is new and/or changed: b3 (added date of event).G3 (date received by manufacturer).G6 (indication that this is a follow-up report).H2 (follow-up due to additional information).H6 (identification of evaluation codes 4114, 4248, 19).The affected complaint sample was not returned for evaluation, and a lot number was not provided; therefore, a retention sample could be obtained and evaluated.However, information was provided from the customer that the olympus esg400 generator was used with settings at 8 cut/12 coag, both on effect 3.Per the vsp550ex ifu, cut mode is not validated with the terumo vsp system on the olympus esg400.Without a returned device, a thorough investigation could not be performed, and a definitive root cause could not be determined.However, the most likely cause is using the device outside of the recommended ifu settings.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: VIRTUOSAPH PLUS WITH RADIAL INDICATION
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 125 blue ball road; elkton, MD 21921 ; 7346634145
• MDR Report Key: 23429810
• Report Number: 1124841-2025-00090
• Device Sequence Number: 8280834
• Product Code: GEI
• UDI-Device Identifier: 00699753450769
• UDI-Public: (01)00699753450769
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K160206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/23/2025

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 Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Supplement Date Received by Manufacturer: 11/03/2025; 12/01/2025
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 11/26/2025; 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown