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Model Number 380652-43 |
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 06/10/2020 |
Event Type
malfunction
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Manufacturer Narrative
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An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The fse was unable to replicate the reported errors 23/30.However, the fse replaced the master tool manipulator left to correct errors 23/30 despite not being able to replicate the errors.The fse also replaced the power supply due to error 417.The fse replaced the remote arm controller (rac) due to error 23/30 messages pointing to a node not present in the ssc.The fse replaced the rac and ran the wheel status with no drops.The fse also replaced the mtml to correct error 23/30.The system was tested and verified as ready for use.The master tool manipulator 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 the right (mtmr).The mtml has been received but failure analysis has yet to be performed on it at this time.When the failure analysis investigation is complete an additional report will be created.Failure analysis investigation could not confirm/replicate the reported issue with the rac.This unit was installed into the test system, running 10 minutes si cycle, 10 power cycles, and sitting idle for one hour.Failure analysis investigation could not replicate the reported issue with the power supply switcher, but did confirm it via system logs.Visual inspection found that the cable has yellow marks.The power supply was installed into a pca xi system and patient side cart powered up in normal mode.It passed communication, voltage/current was checked, fans were running, and ten power cycles were performed without any errors or issue.System log investigation: a review of the system log was conducted and the following additional information was provided: the site needed to disconnect the surgeon side console that was experiencing the faults (serial number (b)(4)) to resolve the reported faults.
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Event Description
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It was reported that during a da vinci-assisted modified radical hysterectomy (malignant) surgical procedure, a non-recoverable fault occurred and an instrument became stuck on tissue.The site had tried power cycling the system prior to calling technical support.The technical support engineer saw error 23 on surgeon side console 1 (ssc1).The site power cycled again and the tse had them perform a hard cycle and emergency power off on the patient side cart.The system powered on with no change; error 23 persisted and the system was stuck in self-test mode.The tse asked the site if they could attempt removing the instrument stuck on tissue.The customer was able to get a lap camera to visualize the tissue and then use the instrument release kit to release the tissue.The tse then had the site power down the system and disconnect ssc 1.The tse also had the site hard cycle and emergency power off the psc and remaining subsystems.The system powered on with no issues or faults with ssc1 disconnected.The customer was able to install instruments and continue with the procedure on ssc2.The procedure was continued as planned with no reported injury.On 06/17/2020, intuitive surgical inc.(isi) contacted the customer site and additional information was obtained about the complaint: this procedure was initially started in a dual-console set-up (a dual-console set-up allows for two ssc's to be used during the same procedure).The ssc that experienced the faults was disconnected and not used again in the procedure.The procedure was completed with the other ssc in the dual-console set-up.There was no patient injury and no fragments that fell inside that patient.The instrument that became stuck on tissue during this procedure was a prograsp forceps instrument.This instrument was discarded without documenting the part number and batch/lot number.
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Event Description
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Refer to h10/h11 for follow-up information.
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Manufacturer Narrative
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4315 - intuitive surgical, inc.(isi) received the parts involved with this complaint and completed the device evaluation.Failure analysis investigation replicated the reported error 30 with the mtm during the sine cycle.Based on this new information, this event remains reportable because the surgeon side cart was disconnected to continue the procedure.The following fields were updated with additional information: g7, h2, h6, h10.The following fields were updated with corrected information: d10.
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Search Alerts/Recalls
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