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

Model Number VSP550EX

Device Problems Smoking (1585); Sparking (2595)

Patient Problem Injury (2348)

Event Date 08/28/2019

Event Type  Injury  

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.(b)(4).

Event Description

The user facility reported to terumo cardiovascular that during vein harvesting procedure, it was noticed that there was a flame coming from the end of the harvester.  as per the user facility, inspection was done on the electro surgical unit with no signs of error.A chemical smell was coming from the patient.The physician assistant removed the scope from the patient's leg and tested the "cut' function of device.It then began sparkling and smoking and the tip looked black and melted.The effect on the patient was not reported.There was a delay for 3-5 minutes.Product was changed out.Procedure was completed successfully.

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 september 16, 2019.Upon further investigation of the reported event, the following information is new and/or changed: (b)(4).The affected sample was not returned so a thorough investigation could not be performed.A video was provided with the complaint to confirm the reported event.From the video, it can be seen that there is significant buildup on the v-cutter.A retention sample from the same product code and lot number combination was obtained.The retention unit was visually inspected, and no anomalies were noted.All electrical circuits were measured, and the electrical resistances were found to be stable and within the product specifications.During the manufacturing process, the v-cutter mechanism is 100% inspected and tested for functionality and performance prior to packaging.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: VIRTUOSAPH PLUS, 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: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 9071738
• MDR Text Key: 158702902
• Report Number: 1124841-2019-00260
• Device Sequence Number: 1
• Product Code: GCJ
• 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: company representative,health
• Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: VSP550EX
• Device Catalogue Number: N/A
• Device Lot Number: 92K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/16/2019
• 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