Model Number 380610-19 |
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 06/12/2020 |
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 master tool manipulator, left (mtml) due to 23031 errors.Following service, the system was tested and verified as ready for use (refer to crm notes for further details).A log review was performed for the si system (usg712) reported in this complaint and the error 23031 on the master tool manipulator (mtm) was confirmed.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 his right (mtmr).The mtm has been returned to isi for evaluation on 6/17/2020 , but is pending failure analysis evaluation.A follow-up mdr will be submitted once additional information is received.This complaint is being classified as a reportable event due to the following conclusion: system unavailability after the start of a surgical procedure (first port incision) lead to the procedure being converted to a laparoscopic procedure.While there was no harm or injury to the patient the customer had to convert to a laparoscopic procedure as the issue with the master tool manipulator (mtm) could not be resolved.The reported failure mode could potentially 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 cholecystectomy procedure the master tool manipulator, left (mtml) was disabled as the surgeon could not control the master.The technical support engineer (tse) reviewed the logs and found an error 23031 on mtml.The tse had the customer power cycle and hard power cycle the system, but the error persisted.The tse informed the customer that a field engineer would need to further troubleshoot the issue and the site converted to a laparoscopic procedure.There was no reported patient injury or harm.Intuitive surgical, inc.(isi) completed customer follow up and confirmed that the laparoscopic surgery was completed with no patient injury and the patient has not experienced any post-operative complications.
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Manufacturer Narrative
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4307 - intuitive surgical, inc.(isi) received the master tool manipulator (mtm) associated with this complaint and completed its investigation.Failure analysis (fa) reproduced the reported error 23031 during calibration.Based on the additional information obtained through fa, this complaint remains a reportable event due to the following conclusion: system unavailability after the start of a surgical procedure (first port incision) lead to the procedure being converted to a laparoscopic procedure.While there was no harm or injury to the patient the customer had to convert to a laparoscopic procedure as the issue with the master tool manipulator (mtm) could not be resolved.The reported failure mode could potentially cause or contribute to an adverse event if it were to recur.
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Event Description
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Refer to h10/h11 for follow-up information.
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Search Alerts/Recalls
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