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

Model Number	VSP550EX
Medical Device Problem Codes	Smoking (1585); Failure to Cut (2587)
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Serious Injury
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.(b)(4).Results: results pending completion of investigation.Conclusions: conclusion not yet available.
Event or Problem Description
The user facility reported to terumo cardiovascular that during vein harvesting, there was a little puff of smoke seen when they tried to use the virtuosaph with the generator up to 100 watts.The unit was not able to cut.Product 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 august 21, 2018.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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 september 6, 2018.(b)(4).Terumo cardiovascular determined this issue is due to the valley lab ft-10 generator not harvesting efficiently and effectively with the virtuosaph under all patient conditions.A previous evaluation did not include challenging the device across multiple tissue conditions.Patients with a large amount of high impedance tissue surrounding the target vessel may more readily cause the recommended generator settings to be ineffective.On a standard generator, an increase in impedance will lead to a slight decrease in the output, but output will remain high enough to continue to cut through tissues as intended.On the valley lab ft-10, an increase impedance can cause the output to reduce with the virtuosaph making it unable to continue with the vessel harvest within the validated range.The virtuosaph is not harvesting efficiently and effectively with the valley lab ft-10 generator within the validated settings range listed in the ifu.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: VIRTUOSAPH PLUS, WITH RADIAL
• Common Device Name: LAPAROSCOPE, GENERAL
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 7803835
• Report Number: 1124841-2018-00193
• Device Sequence Number: 13738840
• Product Code: GCJ
• UDI-Device Identifier: 00699753022966
• UDI-Public: (01)00699753022966
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K160206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: VSP550EX
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 08/20/2018; 09/10/2018
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 09/06/2018; 09/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1124841-08/20/2018-001-C
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VALLEY LAB FT10
• Outcome Attributed to Adverse Event: Other