TERUMO CARDIOVASCULAR SYSTEMS CORPORATION VIRTUOSAPH PLUS, WITH RADIAL; LAPAROSCOPE, GENERAL
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Model Number VSP550EX |
Device Problems
Smoking (1585); Failure to Cut (2587)
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Patient Problem
Injury (2348)
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Event Type
Injury
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Manufacturer Narrative
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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.
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Event Description
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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.
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Manufacturer Narrative
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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.
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Manufacturer Narrative
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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.
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Search Alerts/Recalls
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