INTUITIVE SURGICAL,INC. DA VINCI XI SURGICAL SYSTEM; ENDOSCOPIC INSTRUMENT CONTROL SYSTEM
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Model Number IS4000.A70P6B |
Device Problems
Poor Quality Image (1408); Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/25/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Isi received the unit involved with this complaint, however, the failure analysis investigation is still in progress therefore the root cause of the customer reported failure has not been determined.A follow up mdr will be submitted once the failure analysis has been completed and/or additional information is received.This complaint is being reported due to a da vinci system malfunction rendering the da vinci system unavailable for use after the start of a surgical procedure.Although no patient harm occurred, if this malfunction were to recur it could cause or contribute to an adverse event.
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Event Description
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It was reported that during a da vanci-assisted partial nephrectomy procedure, the customer experienced a loss of light in the left eye of the surgeon side console (ssc).The site attempted to perform a power cycle, however, there was no change.The intuitive surgical, inc.(isi) technical support engineer (tse) had the site power cycle a second time and cycle the ssc breaker, however, the issue persisted.The surgeon completed the procedure with his face outside of the high resolution stereo viewer (hrsv) in the ssc due to the hrsv being black.An isi field service engineer (fse) was dispatched to the facility and was able to reproduce the reported failure.The fse replaced the hrsv left side monitor.The hrsv provides the video image for the ssc.
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Manufacturer Narrative
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Intuitive surgical, inc (isi) has received the high resolution stereo viewer (hrsv) involved with this complaint and completed the device evaluation.Failure analysis investigation confirmed the reported failure.The unit sometimes would have no video; main board defect.The main board has been replaced.This report does not admit that the report or information submitted under this report constitutes an admission that the device, intuitive surgical or intuitive surgical employees, caused or contributed to the reportable event.
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Search Alerts/Recalls
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