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Model Number 380677-17 |
Device Problems
Defective Component (2292); Device Displays Incorrect Message (2591)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/13/2020 |
Event Type
malfunction
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Manufacturer Narrative
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An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The fse replaced the left master tool manipulator (mtm) assembly to address the repeated error 23072 that occurred on axis 5.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.No image or video was shared for the event.Log information was reviewed and errors identified by technical support when troubleshooting with the customer.The isi device has been returned; however, failure analysis investigation has not yet been completed.This complaint is a reportable event due to the following conclusion: system unavailability after the start of a surgical procedure (first port incision) led to the procedure being converted to another da vinci system.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.
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Event Description
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It was reported during a da vinci-assisted prostatectomy procedure the surgical staff encountered an error 41070 occurred and all arm leds were red.Technical support advised the customer to reboot the system, but the error persisted.Technical support reviewed the logs and found there were errors 23000 and 23027 on left master tool manipulator (mtml) axis 5.The surgical staff completed all troubleshooting steps and replaced the surgeon console from another system, which cleared the error (41070).The procedure resumed as planned with no reported patient injury.On 5/27/2020, the intuitive surgical, inc.(isi) representative received additional information regarding the high down failure.The failure occurred on the surgeon hand controller 10 minutes into starting the surgeon side console (ssc).Due to the non-recoverable fault, the customer was advised by dvstat to restart of the system with the circuit breaker turned off, but the surgical staff was unable to recover from the failure.The user had difficulty restarting the system and the surgeon side console (ssc) was replaced with another ssc (sk3007).Despite the procedure delay (approx.15 mins.) due to system troubleshooting, the surgeon resumed and completed the procedure without further issue after converting to another ssc.The site performed an operation check after connecting the defective ssc (sk3008) to an available system, but the fault occurred again.The site explained that fault did not recur after restarting the system.On 6/8/2020, isi representative received additional information regarding the high down failure.It was confirmed that ports were placed when a non-recoverable fault occurred 10 minutes after starting ssc (sk3008).The procedure was completed without issue after the surgical staff changed from ssc sk3008 to sk3007 with no reported patient injury.
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Manufacturer Narrative
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4310 - intuitive surgical, inc.(isi) received the master tool manipulator (mtm) assembly associated with this complaint and completed its investigation.Failure analysis (fa) was unable to reproduce nor confirm the customer reported issue, which was an error 23027.Visual inspection was performed and no damage was noted.The mtm was installed onto in-house test system and powered up with no issues.The mtm completed sine cycle and test drive without any issues.The master tool manipulator (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's side console.One mtm is assigned to the surgeon's left hand (mtml) and one to the right (mtmr).Based on the additional information, this complaint rmains a reportable event due to the following conclusion: system unavailability after start of a surgical procedure (first port incision) led to the procedure to be converted to another da vinci system.While there was no harm or injury to patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.
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Search Alerts/Recalls
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