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); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
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.
Event or Problem Description
The user facility reported to terumo cardiovascular that during vein harvesting, the physician assistant (pa) was harvesting a radial artery, after a couple of branches were cut, an unusual smell (melting plastic) was noticed.The device was pulled out of the arm and noticed sparks coming out of the tip of the harvester device which was melted.There was no harm to the patient.Settings: cut 12 / coag 8 (both on effect 3).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 december 23, 2025.Upon further investigation of the reported event, the following information is new and/or changed: b5 (added describe event or problem).D9 (device availability - added date returned to manufacturer).G3 (date received by manufacturer).G6 (indication that this is a follow-up report).H2 (follow-up due to additional information and device evaluation).H3 (device evaluated by manufacturer).H6 (identification of evaluation codes 10, 11, 3331, 4248, 19).There were 6 unopened samples returned along with 1 used sample.The used sample was inspected upon receipt and confirmed that the v-cutter tip was burnt.The condition of the returned sample did not allow for electrical testing.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.A retention sample from the same lot number was inspected to show no anomalies with the device.All electrical circuits were measured, and the electrical resistances were found to be stable and within the product specifications.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 indicates that an olympus esg400 generator was used.Per the clinical specialist, the proper esg-400 setting that utilizes an effect setting of 3 is to be only used with a coag setting of 8.There should be no cut setting programmed into the olympus esg-400 generator.

• 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: 23876086
• Report Number: 1124841-2025-00114
• Device Sequence Number: 14619987
• Product Code: GEI
• UDI-Device Identifier: 00699753450769
• UDI-Public: (01)00699753450769(17)280131(10)52K
• 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
• Report Date (Section B): 02/20/2026

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 Catalogue Number: N/A
• Device Lot Number: 52K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/02/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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