Model Number 380614-11 |
Device Problem
Defective Component (2292)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/28/2020 |
Event Type
malfunction
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Manufacturer Narrative
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An isi fse was dispatched to the customer site to further investigate the reported complaint.The fse replaced the ecm.The system was tested and verified as ready for use.Isi has not received the ecm for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if additional information is obtained.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.Based on the information provided at this time, this complaint is being reported due to the following conclusion: system unavailability after start of a surgical procedure (first port incision) could lead to the procedure to be converted/aborted.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.
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Event Description
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It was reported that during a da vinci-assisted surgical procedure, the endoscopic camera manipulator (ecm) insertion axis was stuck.The procedure was converted to open surgery with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter on (b)(6) 2021 and obtained the following additional information: the system functionality was checked upon powering on the system.There were no issues noted during setup.When the issue occurred, the patient was under anesthesia and the ports were placed.The procedure had been in progress for 10 minutes.The site contacted the field service engineer (fse) to troubleshoot the issue during the procedure and completed all troubleshooting steps prior to converting the surgery to open.The patient tolerated the open procedure normally.There was no injury or harm to the patient and the patient did not experience any post-operative complications.A video recording of the procedure is not available for isi review.
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Manufacturer Narrative
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D02- isi received the endoscopic camera manipulator (ecm) involved with this complaint and completed the device evaluation.Failure analysis investigation reproduced the reported failure.There was non-intuitive motion along the insertion/ axis 3 during a test drive.
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Event Description
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Refer to h10/h11 for follow-up information.
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Search Alerts/Recalls
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