MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION VIRTUOSAPH PLUS EVH SYSTEM WITH RADIAL; LAPAROSCOPE, GENERAL

Model Number VSP550EX

Device Problem Electrical Power Problem (2925)

Patient Problem Burn(s) (1757)

Event Date 02/28/2024

Event Type  Injury  

Event Description

The user facility reported to terumo cardiovascular that during vein harvesting procedure, the patient suffered a skin burn in which terumo considers as serious injury.There was no delay, the product was not changed out, and the procedure was completed successfully with no blood loss.

Manufacturer Narrative

The affected sample was not returned for evaluation; therefore, a thorough investigation could not be performed, and a definitive root cause could not be determined.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.Based on review of past complaints, the cracked/fractured/burnt 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 EVH SYSTEM WITH RADIAL
• Type of Device: LAPAROSCOPE, GENERAL
• 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: 18962085
• MDR Text Key: 338388499
• Report Number: 1124841-2024-00039
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00699753450769
• UDI-Public: (01)00699753450769
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160206
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VSP550EX
• Device Catalogue Number: N/A
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other