Based on the information provided, the cause of the customer reported failure mode and intra-operative complication cannot be determined.The surgeon reported that their site is keeping the vse instrument used during this event for inspection.Attempts to retrieve the instrument from the customer have been unsuccessful.A follow-up mdr will be submitted if additional information is obtained.The reported issue was addressed with phone support.The isi field service engineer (fse) contacted the customer robotics coordinator who reported that the system this event occurred on has been working without issue since this reported event.The customer reported that no instrument have come loose since this reported incident.This information led the fse to conclude that this event was caused by a sterile drape issue.No site visit was conducted.The system was working properly and no additional action was required.A review of the system logs for the procedure date of (b)(6) 2022 has been performed by a technical support engineer (tse) and the following was observed: multiple procedures have been performed on this system after this reported complaint.No relevant errors were observed during this procedure.The system used during this procedure was remotely updated to software p9f on (b)(6) 2022.As a result of this review, the tse did not recommend a field service engineer (fse) visit the site to perform additional on-site system verification testing.An isi failure analysis engineer reviewed the instrument logs for the vse instrument used during this event and provided the following information: there were no errors that would suggest an instrument failure in the logs.There were no engagement failure or system errors related to this event noticed in the logs.This complaint is being reported due to the following conclusion: during a da vinci-assisted paraesophageal hiatal hernia procedure, it was alleged that the vse instrument moved unexpectedly and damaged the liver.Cautery and surgicel were applied to resolve the liver bleeding.The cause of the customer reported failure mode and intra-operative complication cannot be determined.
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It was initially reported that during a da vinci-assisted paraesophageal hiatal hernia procedure that the vessel sealer extend (vse) instrument jaw moved unexpectedly while installed on arm2 and "put a hole in the liver of the patient." the instrument was reportedly not responding to the surgeon's commands via the surgeon side console (ssc) controls, and "flexed and jumped at the jaw" to damage the liver.There was reported bleeding which was controlled via unknown means.The vse instrument was replaced and the procedure was continued as planned.The customer reported that there were no instrument collisions at the time of this event.The intuitive surgical, inc.(isi) technical support engineer (tse) observed no relevant errors in the system logs.The tse told the customer that the issue could be related to the instrument and sterile adapter.The patient was reportedly in stable condition.On 09-feb-2022, isi contacted the surgeon of this procedure and additional information was obtained about the complaint: the vse instrument was in use for about 20 minutes and was working fine before this event occurred.The surgeon reported: ¿i was moving the vessel sealer straight forward towards the hiatus and starting to rotate it.The instrument bent up at almost a 90 degree angle at the wrist and rotated sharply to my right, dragging the tip right through the undersurface of the left lobe of the liver.¿ it was reported that this event caused some bleeding from the liver which the surgeon described as ¿not much.¿ the bleeding was resolved with pressure and bipolar cautery.The surgeon then placed surgicel on the liver surface after the bleeding was controlled with cautery.The surgeon reported that this event delayed the procedure less than 15 minutes but had no other impact.There surgeon reported this event had no impact on the patient and they have no concern of any long-term complications with the patient due to this event.The patient did not experience any post-operative complications and was ¿discharged post op day 2 per routine.¿ the surgeon said they are unsure what caused this event but theorized that it might have been caused by a an input disc engagement issue or a wire issue.The surgeon reported there were no internal or external arm collisions prior to this event.Reportedly, only the vse instrument wrist moved during this event.The surgeon reported that this vse instrument was kept by their site to be inspected.There were no videos or photos taken of this event.
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