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Model Number 380677-16 |
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 03/28/2022 |
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.The reported complaint was confirmed based on the field evaluation.The isi fse replaced the personality module surgeon console (pmsc) and generic power distributor (gpd).The system was tested and verified as ready for use.Isi has received the pmsc and gpd, however, failure analysis has not completed their investigation.Therefore, the root cause of the alleged customer reported failure mode has not been determined.A follow-up mdr will be submitted upon completion of the failure analysis evaluation and if additional information is received.A review of the site's complaint history found no additional complaints related to this complaint.No image or video was available for review.A review of the site's system logs for the reported procedure date was performed by technical support when the customer called for troubleshooting assistance and found a low current class 0 error for one of the monitors which might not be related to the reported issue.An event verification via the system logs could not be performed because there is insufficient event date information.This complaint is considered a reportable malfunction event due to the following conclusion: it was alleged that the left eye on the surgeon side console (ssc) had no image on one of the doctor's consoles.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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Event Description
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It was reported that during a da vinci-assisted surgical procedure, the left eye was not working and had no image on one of the surgeon side consoles (ssc).The customer confirmed that one console had an image in both eyes and one had an image only in the right eye.The procedure was continuing as planned with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information on 20th april, 2022: the customer was unable to provide any additional information.
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Search Alerts/Recalls
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