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Model Number 380652-40 |
Device Problem
Visual Prompts will not Clear (2281)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/30/2022 |
Event Type
malfunction
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Manufacturer Narrative
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An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The fse confirmed universal surgical manipulator (usm) 3 had non-recoverable 319 faults at startup and had to be disabled to continue.Fse saw loose cables inside the arm obstructing carriage movement in the insertion axis.Fse replaced usm to resolve the reported problem.The system was tested and verified as ready for use.Isi received the usm involved with this complaint, and the device evaluation was completed.The error 319 was confirmed and reproduced.The unit was tested on an in-house system and failed normal mode as the axes controller, carriage (acc) board was not detected.The unit was also tested on a pftp and passed lissajous, insertion buttons, sine cycle, and brake test but failed the fiber test.After further investigation the rolling loop fiber was found to be damaged.The original rolling loop was cut out and removed.A gold fiber was installed and the error no longer occurred.The root cause of the reported issue was attributed to a component failure.A review of the site's complaint history does not reveal any related complaints involving this product or this event.No image or video clip for the reported event was submitted for review.A review of the site's system logs for the reported procedure date was conducted by isi technical support when the customer called for support and by the field service engineer (fse) while investigating onsite.Investigation revealed multiple errors that were related to the reported complaint occurred during the surgical procedure.Additional log reviews confirmed that system (b)(4) was used on (b)(6) 2022 for a cholecystectomy procedure.This complaint is being classified as a reportable event due to the following conclusion: an arm was abandoned after the start of the procedure and the surgeon was able to continue with the procedure robotically using 3 arms.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.System unavailability after start of a surgical procedure could lead to the procedure to be converted and may lead to an injury due to the patient's inability to tolerate a conversion.
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Event Description
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It was reported that during a da vinci-assisted cholecystectomy surgical procedure, the staff was encountering a repeated error on arm 3 during the procedure.The staff contacted intuitive surgical, inc.(isi) technical support for assistance.The staff had tried to recover from the error repeatedly, but was not successful.The reporter explained they had power cycled the system two times with no change.Isi technical support engineer (tse) walked the staff through a hard power cycle of the patient side cart (psc) with no change.Onsite logs reflect error 32114, 40084 and 319 pointing to universal surgical manipulator (usm) 3 axes controller carriage (acc) node.The surgeon elected to disable usm3 and proceeding with the procedure using usm1, usm2 , and usm4.The procedure was completed as planned with no reported injury.On 07-apri-2022 , isi contacted the initial reporter and obtained the following information.The procedure was completed using 3 arms instead of 4.There was no injury to the patient.
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Search Alerts/Recalls
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