MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI S SURGICAL SYSTEM; SURGEON SIDE SYSTEM

Model Number 380429-02

Device Problem Device Issue (2379)

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

Event Date 03/25/2018

Event Type  malfunction  

Manufacturer Narrative

On 28-mar-2018, an isi field service engineer (fse) performed a field evaluation at the site.The fse resolved the customer reported issue by replacing the mtmr.The fse then tested the system and verified that it was ready for use.As of the date of this report, the mtmr has not been returned to isi for evaluation.Therefore, the root cause of the customer reported failure mode cannot be determined.Isi has reviewed the site's system logs with an event date of (b)(6) 2018.Multiple repeated error #23009 were generated on the date of the event.Based on the information provided at this time, 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 planned da vinci-assisted prostatectomy procedure, the surgical staff encountered a repeated error #23009 pointing to the right master tool manipulator (mtmr).An error #23009 is generated when the system detects an unexpected jump in encoder signal.This error can be caused by a failed encoder or when manipulators collide.The error can also occur when the patient side manipulators (psm) or arms are moved around during setup.The site contacted an intuitive surgical, inc.(isi) technical support engineer (tse) for assistance.The site tried moving the mtms and restarted the system several times.However, the error #23009 issue was not resolved.Due to the alleged error message issue, the surgeon made the decision to abort the planned surgical procedure after anesthesia had already been administered to the patient.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the right master tool manipulator (mtmr) involved with this complaint and completed investigations.Failure analysis was able to replicate the reported error, #23009 on axis 2, during normal mode.The axis 2 second stage cables were found to have low cable tension and were replaced as a fix for the field reported error.This complaint will remain reportable due to the following conclusion: based on the information provided at this time, 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.

• Brand Name: DA VINCI S SURGICAL SYSTEM
• Type of Device: SURGEON SIDE SYSTEM
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• MDR Report Key: 7398155
• MDR Text Key: 104807873
• Report Number: 2955842-2018-10113
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380429-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2018
• Date Manufacturer Received: 04/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES