TERUMO CARDIOVASCULAR SYSTEMS CORPORATION VIRTUOSAPH PLUS, WITH RADIAL; LAPAROSCOPE, GENERAL
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Model Number VSP550EX |
Device Problems
Smoking (1585); Sparking (2595)
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Patient Problem
Injury (2348)
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Event Date 08/02/2019 |
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).
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Event Description
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The user facility reported to terumo cardiovascular that during vein harvesting procedure, the unit was seen smoking and sparking.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 august 20, 2019.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.Upon further investigation of the reported event, the following information is new and/or changed: (b)(4).Method code #1: (b)(4).Testing of actual/suspected device.Method code #2: (b)(4).Analysis of production records.Method code #3: (b)(4).Analysis of data provided by user/third party.Results code: (b)(4).Improper physical structure.Conclusions code #1(b)(4).Unintended use error caused or contributed to event.Conclusions code #2: (b)(4).Cause traced to component failure.The affected sample was inspected upon receipt.The inspection showed burn marks on the v-cutter.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.Based on the evaluation of the unit, the cracked/fractured distal end of the v-cutter most likely resulted from excessive force applied to the distal end of the v-cutter during the procedure.The charred section of the v-cutter was like caused by the v-cutter was cracked/fractured and the electric path for high frequency current was exposed or a short circuit occurred, causing the v-cutter to be charred.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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