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Model Number 380677-03 |
Device Problem
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 06/02/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Isi fse was dispatched to the customer site to further investigate the reported complaint.The reported complaint was confirmed based on the field evaluation.The fse replaced the mtml to resolve the issue.The system was tested and verified as ready for use.The mtm refers to the master controllers which provide the means for the surgeon to control the instruments and endoscope inside the patient from the surgeon's side console.One mtm is assigned to the surgeon's left hand (mtml) and one to his right (mtmr).Isi has received the mtml, however, failure analysis has not yet begun.Site history review: as of (b)(6) 2020, a review of the site's complaint history does not show any additional complaints related to this product and/or this event.Image/video review: no investigation required as no image or video clip for the reported event was submitted for review.This complaint is being reported because system unavailability after start of a surgical procedure (first port incision) contributed to the procedure being converted.Although there was no patient harm reported, if this malfunction were to recur it could cause or contribute to an adverse event.
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Event Description
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It was reported that prior to the start of a da vinci-assisted surgical procedure, the customer observed re-occurring error 1 pointing to left master tool manipulator.There was no reported injury.Intuitive surgical, inc.(isi) obtained the following information about the complaint: the patient was administered anesthesia.The system was docked but surgery did not commence.The customer thought the issue was with a universal side manipulator for which they were going to proceed with 3 arms.However, it was ascertained the issue was the master tool manipulator at which point they paused.Technical support advised that it was error 1.Field service engineer advised the customer to undock and do a hard reset.However, the error could not be cleared.The procedure was converted to laparoscopy.
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Manufacturer Narrative
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4307 - intuitive surgical, inc.(isi) received the left master tool manipulator (mtml) involved with this complaint and completed the device evaluation.Failure analysis investigation reproduced the reported failure during calibration.Based on the additional information received, this event remains reportable.
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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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