The user facility reported to terumo cardiovascular that during vein harvesting procedure, it was noticed that there was a flame coming from the end of the harvester. as per the user facility, inspection was done on the electro surgical unit with no signs of error.A chemical smell was coming from the patient.The physician assistant removed the scope from the patient's leg and tested the "cut' function of device.It then began sparkling and smoking and the tip looked black and melted.The effect on the patient was not reported.There was a delay for 3-5 minutes.Product was changed out.Procedure was completed successfully.
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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 16, 2019.Upon further investigation of the reported event, the following information is new and/or changed: (b)(4).The affected sample was not returned so a thorough investigation could not be performed.A video was provided with the complaint to confirm the reported event.From the video, it can be seen that there is significant buildup on the v-cutter.A retention sample from the same product code and lot number combination was obtained.The retention unit was visually inspected, and no anomalies were noted.All electrical circuits were measured, and the electrical resistances were found to be stable and within the product specifications.During the manufacturing process, the v-cutter mechanism is 100% inspected and tested for functionality and performance 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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