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Model Number 400180 |
Device Problem
Arcing (2583)
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Patient Problem
Burn(s) (1757)
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Event Date 01/26/2022 |
Event Type
malfunction
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Event Description
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It was reported that during a hysterectomy procedure, the customer had witnessed arcing when using the monopolar curved scissors (mcs) instrument and uterus tissue was burned.The customer said that they observed a crack in the mcs tip cover accessory.Intuitive surgical, inc.(isi) contacted the surgeon and the surgical tech and obtained the following additional information regarding the reported event: the customer removed the mcs instrument and noticed a hole in the mcs tip cover accessory.There was no damage to the instrument.The customer removed the faulty mcs tip cover accessory, installed a new one, and then continued with the procedure.The reporter stated that the energy settings were set at three or four.The customer confirmed that the mcs did not burn any other tissue besides the uterus.The customer stated they followed the proper installation guidelines, and after the tip cover accessory was placed on the instrument, they put electrolube on the tip to prevent tissue from sticking to the jaws.There was no medical intervention required to address the issue.The customer reported that they would not return the mcs instrument or the tip cover accessory to isi for analysis.They reported that since they had no further issues with the mcs instrument once the tip cover accessory was changed, they sent it to reprocessing.
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Manufacturer Narrative
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The site has discarded the mcs tip cover accessory used during the da vinci-assisted surgical procedure.Therefore, the root cause of the alleged customer-reported issue cannot be determined.A review of the site¿s system logs reveals that the mcs instrument has been used in subsequent surgical procedures.As of the date of this report, no complaints have been reported to isi involving the mcs instrument.If additional information is obtained, a follow-up mdr will be submitted.A review of the site's system logs for the reported procedure date was conducted.Investigation revealed there were no related system errors to have occurred during the surgical procedure that would have likely caused or contributed to the reported complaint.No image or video clip for the reported event was submitted for review.No other complaints have been received for this reported event.This complaint is being reported as a malfunction due to the following conclusion: during a da vinci-assisted hysterectomy surgical procedure, there was an arcing event involving an mcs instrument and mcs tip cover accessory.As a result, the uterus being removed as a part of the procedure was burned.However, at this time, the cause of the arcing cannot be determined.
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Search Alerts/Recalls
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