Intuitive surgical, inc.(isi) received the vessel sealer extend instrument involved with this complaint and completed the device evaluation.The failure analysis investigation confirmed the reported complaint.The instrument was found to have a dislodged blade.The visual inspection showed that the blade was exposed outside of the blade garage 0.123".No conductor wire damage or snake wrist damage was found.There was significant bio debris found at the instrument tip.A log review showed 1 blade exposed failure error 22025, stating "vessel sealer blade cannot retract ".Upon visual inspection, the jaw ceramic dots were visible, and the knife slot measured at 0.026".The instrument was placed on the in-house system and passed self-test from the blade manually retracting itself.The root cause of dislodged instrument blades is typically attributed to mishandling/misuse.The sealing test for this instrument could not be performed because the instrument was returned with the energy delivery cord cut.Based on the information provided, the cause of the reported complication cannot be determined.A follow-up mdr will be submitted if additional information is obtained.No images or videos were shared for the event.A review of the instrument log of the vessel sealer extend instrument (part # 480422-01 / lot # l90220329-0275) associated with this event has been performed.Per the logs, the instrument was last used on (b)(6) 2022 on system sk4906 for a sigmoid colectomy procedure.This is a single use instrument.A review of the site's system logs was conducted and revealed the following possible related system errors: error 22025 - vessel sealer blade cannot retract on pctp.An advance failure analysis engineer performed a log review on the vessel sealer extend instrument and found the following: according to the logs there was an instance of a cut failure reported by the logs.Immediately after there was another instance of the blade becoming jammed, and eventually recovered.Blade jamming can often occur when there is too much tissue within the jaws which prevents the blade from traveling its full distance.Within a minute after the jam the blade was recovered and then the user decided to use a different vessel sealer to complete the procedure.No sealing issues were found in the logs.This event is being reported due to the following conclusion: during a da vinci-assisted sigmoid colectomy surgical procedure, the vessel sealer extend instrument reportedly did not complete a seal even though audible beeps from the generator signaled the seal was complete.As a result, the surgeon encountered minimal bleeding and used a fenestrated bipolar instrument to control the bleeding.Blank mdr fields: follow-up was attempted, but the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section is not applicable.Field d6 is blank because the product is not implantable.Information for the blank fields in section e1 is not available.Field is blank because it is unknown if the initial reporter submitted a report to the fda.Fields are not applicable.
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It was reported that during a da vinci-assisted sigmoid colectomy surgical procedure, the customer reported that the blade was exposed on a vessel sealer extend instrument.The procedure was completed robotically.Intuitive surgical, inc.(isi) obtained additional information from the isi clinical territory associate (cta).The cta was in the room when the issue occurred and was informed that the instrument was inspected prior to use with no damage noted.The surgical task being performed at the time was a seal and then cut.There was a blade exposed message displayed after the surgeon tapped the yellow pedal twice to cut.The error did not occur during sealing.The target tissue at the time was mesentery, there was tissue effect observed, and the tissue was not under tension during the sealing and cutting attempt.The tissue was not exposed to radiation or chemotherapy prior to the procedure.The jaws did not come into contact with a clip, suture, staple, or other metal objects when the reported issue was noted.The jaws were not immersed in a liquid or contaminated by carbonized tissue (bio debris) prior to or during the sealing cycle.The seal cycle completed with the expected fast audible tones.There was a small amount of tissue that was not sealed which resulted in minimal unexpected bleeding, although the exact amount of blood loss that occurred was unknown.The surgeon was able to get the bleeding under control quickly using a fenestrated bipolar instrument.The surgeon does not know what caused the reported issue.No photographic image or video was available to review.There were no further issues or harm to the patient.
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