Model Number IS4000 A70P7B |
Device Problems
Device Displays Incorrect Message (2591); 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 12/11/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4) has not received the unit for failure analysis.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if 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 vinci-assisted surgical procedure, the customer experienced an error on the right master tool manipulator (mtm).The mtm refers to the master controllers which provide the means for the surgeon to control the instruments and endoscope inside the patient from the surgeon side console (ssc).One mtm is assigned to the surgeon's left hand (mtml) and one to the right (mtmr).The procedure was converted to laparoscopic surgery.There was no report of patient harm, adverse outcome or injury.(b)(4) (isi) received the following additional information: the robot worked without issue before the error occurred.Troubleshooting was performed, however, the surgeon was unable to continue with the surgery.The conversion was not planned but the case completed laparoscopically without harm to the patient.An isi field service engineer (fse) was dispatched to the site and was able to reproduce the reported failure and verified the error through the logs.The fse replaced the mtm to resolve the issue.
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Manufacturer Narrative
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Intuitive surgical, inc.(isi) has received the master tool manipulator (mtm) involved with this complaint and completed investigation.Failure analysis investigation reproduced the reported failure during sine cycle.
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Search Alerts/Recalls
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