TERUMO CARDIOVASCULAR SYSTEMS CORPORATION VIRTUOSAPH PLUS, WITH RADIAL; LAPAROSCOPE, GENERAL
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Model Number VSP550EX |
Device Problem
Defective Component (2292)
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Patient Problem
Insufficient Information (4580)
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Event Type
malfunction
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Event Description
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An initial report under uf/importer number: (b)(4) was received at terumo cardiovascular that the yellow button was hard to push up.As per the report, patient was scheduled for a cabg x 4, left atrial appendage exclusion.However, it is unknown when the issue occurred, if the product was changed out or if there was any effect on the patient as a results of the surgery.Terumo continues to gather the necessary information pertaining to this event.
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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).
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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 june 15, 2022.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).H6 (identification of evaluation codes 4114, 3221, 4315).Type of investigation: 4114 - device not returned.Investigation findings: 3221 - no findings available.Investigation conclusions: 4315 - cause not established.The affected sample was not returned for evaluation.A retention sample could not be obtained as the lot number was not provided.Without a returned device or a lot number provided, a thorough investigation could not be performed and a definitive root cause could not be determined.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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