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Model Number 380614-15 |
Device Problems
Defective Component (2292); Device Displays Incorrect Message (2591)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/25/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Mechanical problem.An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The fse replaced the remote arm controller (rac), patient back plane (pbp), generic cart controller (gcc), and pbp-to-rac low voltage differential signaling (lvds) cable.The system was tested and verified as ready for use.Isi received the rac involved with this complaint ,and completed the device evaluation.Failure analysis investigation could not reproduce the reported failure.The board was installed into a test system and ran sine cycle for 10 minutes, 20 power cycles, and sat idle for 1 hour without any errors.There was no trouble found.Isi received the pbp involved with this complaint ,and completed the device evaluation.Failure analysis investigation found the j42 connector was bent.The board could not be installed in the test system.Isi received the gcc involved with this complaint, and completed the device evaluation.Failure analysis investigation could not reproduce the reported failure.The board was installed into a test system and ran sine cycle for 10 minutes, 20 power cycles, and sat idle for 1 hour without any errors.There was no trouble found.The pbp-to-rac lvds cable is a field scrap item, and will not be returning to isi for further investigation.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.No image or video clip for the reported event was submitted for review.Based on the information provided at this time, this complaint is being reported due to the following conclusion: system unavailability after the start of a surgical procedure (first port incision) contributed to the procedure being converted to laparoscopic.Although there was no report of patient injury, if this event were to recur it could cause or contribute to an adverse event.Follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.
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Event Description
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It was reported that during a da vinci-assisted total hysterectomy surgical procedure, there was an endoscopic camera manipulator (ecm) failure and error 23 kept reoccurring.The technical support engineer (tse) reviewed the logs, and confirmed error 23 pointing to a wheel hardware fault along with error 30 pointing to an issue with the remote arm controller (rac).The customer undocked the arms, exercised them in all directions, power cycled the system with an emergency power off (epo), and reseated the blue fiber cables, however, the error persisted.The procedure was converted to laparoscopic surgery with no reported injury.Intuitive surgical, inc.(isi) made multiple follow up attempts to obtain additional information, however, no further details have been received as of date of this report.
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Search Alerts/Recalls
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