TERUMO CARDIOVASCULAR SYSTEMS CORPORATION VIRTUOSAPH PLUS, WITH RADIAL; LAPAROSCOPE, GENERAL
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Model Number VSP550EX |
Device Problem
Flare or Flash (2942)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/05/2021 |
Event Type
Injury
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Manufacturer Narrative
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Terumo has received the device for evaluation; however, 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 references evaluation conclusion code.(b)(4).
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Event Description
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The user facility reported to terumo cardiovascular that during vein harvesting, charred and burnt mark was seen over the tip of the dissector.Additionally, the brand used for the generator was olympus that was set to 8 wattage.The product was changed out.Procedure was 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 january 26, 2021.Type of investigation #1: 10 - testing of actual/suspected device.Type of investigation #2: 11 - testing of device from same lot/batch retained by manufacturer.Type of investigation #3: 3331 - analysis of production records.Investigation findings: 120 - electrical problem identified.Investigation conclusions: 19 - cause traced to user.The affected sample was inspected upon receipt and confirmed to have burn marks and a hole in the v-cutter.A representative retention sample was reviewed and electrically tested with no anomalies and all electrical tests within specification.The v-cutter on the retention sample was fully intact.During the manufacturing process, all vsp550 are visually inspected and tested for functionality and performance along with inspection for v-cutter mechanism, prior to packaging.All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.
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