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Model Number 380652-37 |
Device Problem
Failure to Sense (1559)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/23/2022 |
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.Fse arrived on site and confirmed instrument the clutch button was not working.The fse replaced the universal surgical manipulator (usm).The system was tested and verified as ready for use.Isi received the usm involved with this complaint and completed the device evaluation.Failure analysis was able to confirm/reproduce the 25745 error.The unit was tested on a in house system and failed normal mode as it triggered 25745 error.The unit also failed the instruments insertion button test.The instruments insertion acsb1 board was swapped with a new one and the errors no longer occurred.The original acsb1 board was reinstalled and the errors returned.The unit was tested on a pftp with a new acsb1 board and passed direction tests, lissajous, cva characterization, sensors check, sine cycle, friction test, carriage friction test, brake release test, brake hold test, advanced brake test, carriage strength test, and carriage switches test.The insertion instrument acsb1 board assembly and ffc will be replaced as a fix to the reported problem.Update : the correct part that was failing was the instrument clutch switch, which was causing the 25745 error.The insertion instrument acsb1 board will be replaced because it was too dim.A review of the site's complaint history does not show any additional complaints for this product.No image or procedure video was provided 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.Investigation revealed error 25745 - psc button unstable that was related to the reported complaint occurred during the surgical procedure.Additional log reviews confirmed that system sk1114 was used on 23-mar-2022 for a gastric bypass (roux-en-y) 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 gastric bypass (roux-en-y) surgical procedure, the arm 4 instrument clutch was not working.The intuitive surgical, inc.(isi) clinical sales associate (csa) contacted isi technical support and informed the technical support engineer (tse) that the customer tried reseating the drape and instrument, but it did not resolve the issue.The csa stated when they undock arm 4 without the cannula, the instrument clutch would work normally, but as soon as they dock the arm it would stop working.The csa stated the clutch button did not appear to be sticking or damaged.The csa stated that the instrument clutch leds light up, but the arm did not respond when trying to insert the instrument.The csa stated they also tried hard power cycling the patient side cart (psc), but with no success.Tse reviewed the system error logs and discovered multiple informational 25745 errors present reported by arm 4 instrument clutch.The csa stated that the customer was proceeding with the system as is.The procedure was completed with no reported injury.On (b)(6) 2022, isi contacted the initial reporter and obtained the following information: the procedure was completed as a 3 arm system with no further complications.There was no patient impact or harm.
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Search Alerts/Recalls
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