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

Model Number	VSP550EX
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Terumo has received the device for evaluation; however, 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 tip broke before the upper limb could be harvested.After the dissection was finished, they started harvesting the saphenous vein from the lower limb.The device worked smoothly during that part.When they moved on to the upper limb, things got tricky.While guiding the harvester in and out of the tunnel, the white v-cutter tip snapped off as they were inserting it.The tip broke before the upper limb could be harvested.Since the device was no longer usable, they had to open a second virtuosaph to finish harvesting the vein from the upper limb.The rest of the procedure went ahead without any further problems.No known consequences to the patient.Product was changed out.Procedure 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 24, 2025.Upon further investigation of the reported event, the following information is new and/or changed: b5 (updated describe event or problem).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 received indicates that a valley lab generator was used, it was on a bipolar set, macro on 6, and the settings were not modified.
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: 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, 3259, 19).The affected sample was inspected upon receipt and confirmed that the one side of the v-cutter was broken off.A retention sample from the same lot number was inspected to show no anomalies with the device and a fully intact v-cutter.During the manufacturing process, all vsp550 units are visually inspected and tested for functionality and performance along with inspection for v-cutter mechanism, prior to packaging.The cracked/fractured distal end of the v-cutter most likely resulted from excessive force applied to the distal end of the v-cutter during the procedure.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: 23384525
• Report Number: 1124841-2025-00088
• Device Sequence Number: 11991038
• Product Code: GEI
• UDI-Device Identifier: 00699753450769
• UDI-Public: (01)00699753450769(17)270930(10)4XK
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/18/2025

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: Other
• Device Model Number: VSP550EX
• Device Catalogue Number: N/A
• Device Lot Number: 4XK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Supplement Date Received by Manufacturer: 10/23/2025; 11/24/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 11/14/2025; 12/18/2025
• 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 Age: 62 YR
• Patient Sex: Male