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Model Number 380677-12 |
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 03/14/2022 |
Event Type
malfunction
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Event Description
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It was reported that during a da vinci-assisted unilateral inguinal hernia surgical procedure, the staff was experiencing a recoverable fault and a left hand control disabled message.Prior to calling intuitive surgical, inc.(isi) technical support, the customer attempted a system restart and changed instruments.The isi technical support engineer (tse) viewed live logs and noted error 23032 on the left master tool manipulator (mtm).The button appeared to be pressed at startup.Tse had caller perform a hard reboot of the system.Tse also had caller exercise opto-switches on the left mtm.System powered back up with the recoverable fault still present.Tse had caller bring in another surgeon console from a robot not being used.The customer connected the surgeon console and system powered on and the "da vinci is ready" was heard.The system was redocked and the surgeon took control of instruments and was continuing with procedure.The procedure was converted to another da vinci system and there was no reported injury to the patient.On 16-mar-2022, isi contacted the original reporter and obtained the following information about the complaint: there was no injury to the patient and no fragments fell into the patient.
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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 found the opto switch sticking and not responding.After moving the opto switch around, it released and looked to be working.Fse replaced the master tool manipulator (mtm) to correct issue.The system was tested and ready for use.Isi received the mtm involved with this complaint and completed the device evaluation.Failure analysis (fa) was able to reproduce the reported issue (opto switch sticking and not responding) during calibration.The opto button assemblies will be replaced as a fix to the reported problem.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.Investigations revealed error 23032, however, error 23032 could not be found on system sk1341 logs.This complaint is being classified as a reportable event due to the following conclusion: the customer converted after the start of the procedure due to non-recoverable errors.While there was no harm or injury to the patient, system unavailability after the start of a surgical procedure could likely cause or contribute to an adverse event if it were to recur as it may lead to an injury due to the patient¿s inability to tolerate a conversion.
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Search Alerts/Recalls
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