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Model Number 380940-33 |
Device Problem
No Display/Image (1183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/15/2022 |
Event Type
malfunction
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Event Description
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It was reported that during a da vinci-assisted oropharyngectomy surgical procedure, the customer lost the left eye vision on the surgeon side console (ssc).The customer reseated the endoscope, power cycled the system, and hard power cycled the ssc with no resolution.The customer confirmed that the left eye vision could be seen on the vision side cart (vsc) and on the third-party monitor.There was no report of patient injury as a result of the reported issue.Intuitive surgical, inc.(isi) followed up with the da vinci coordinator and obtained additional information: the surgeon was able to complete the procedure robotically without the left eye.
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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 replaced the high resolution stereo viewer (hrsv) on the surgeon side console (ssc) to resolve the reported issue.The system was tested and verified as ready for use.Isi received the hrsv involved with this complaint and completed the device evaluation.Failure analysis investigation replicated the reported complaint.The unit was installed into the test system, and it powered up the surgeon side console (ssc) without the left eye vision.A review of the site's complaint history does not reveal any additional complaints involving this product and/or this event.A review of the site's system logs for the reported procedure date was conducted.Investigation revealed the following possible related system error: 119 (console hrsv low current: the hrsv monitors in ssc2 have a total current draw from the fpd that is lower than threshold).No image or video clip for the reported event was submitted for review.This complaint is considered a reportable event due to the following conclusion: the customer lost vision on the left side of the surgeon side console (ssc) during the da vinci-assisted surgical procedure.The customer was able to complete the procedure robotically; however, the loss of left eye vision could lead to the procedure being converted or aborted.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 procedure change.
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Search Alerts/Recalls
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