MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. DA VINCI SI SURGICAL SYSTEM; ENDOSCOPIC INSTRUMENT CONTROL SYSTEM

Model Number IS3000 A60P9B

Device Problems Device Issue (2379); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/17/2017

Event Type  malfunction  

Manufacturer Narrative

The psm was returned for failure analysis, and the reported system error code 23034 was unable to be reproduced.However, the system error code 23034 was confirmed as having occurred via the site's system logs.A visual inspection was performed.The psm was installed onto a system and powered up.A sine cycle and a test drive were performed without any issues.Tests performed via matlab passed.Parts were replaced as a precaution.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.

Event Description

It was reported that during a da vinci-assisted inguinal hernia repair procedure, the surgical staff was encountering a non-recoverable fault.Prior to contacting an intuitive surgical, inc.(isi) technical support engineer (tse) for assistance, the initial reporter rebooted the da vinci surgical system a couple of times.The tse reviewed the site's system logs.According to the tse, the system logs showed a system error code 23034 on arm 1 followed by a non-recoverable system error code 307.A system error code 23034 is generated when the system detects a stuck cannula port clutch switch.The tse instructed the site to reboot the system again.However, the same system error occurred again.As a result, the surgeon made the decision to convert the da vinci-assisted inguinal hernia repair procedure to traditional laparoscopic surgery.According to the initial reporter, the event occurred towards the end of the surgical procedure.The surgical procedure was completed successfully via traditional laparoscopic surgery and no post-operative complications have been reported.On (b)(4)2017, an isi field service engineer (fse) performed a field evaluation at the site.The fse was able to reproduce the customer reported failure mode and replaced the patient side manipulator 1 (psm1) to resolve the issue.The psm is an instrument arm located on the patient side cart (psc) that provides sterile interface for the endowrist instrument.

• Brand Name: DA VINCI SI SURGICAL SYSTEM
• Type of Device: ENDOSCOPIC INSTRUMENT CONTROL SYSTEM
• Manufacturer (Section D): INTUITIVE SURGICAL,INC.; sunnyvale CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC.,; 950 kifer rd; sunnyvale CA
• Manufacturer Contact: tabitha reed ; 950 kifer rd; sunnyvale, CA ; 4085232420
• MDR Report Key: 7028485
• MDR Text Key: 93098885
• Report Number: 2955842-2017-00768
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IS3000 A60P9B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/17/2017
• Initial Date FDA Received: 11/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1