MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; PATIENT SIDE CART, 4-ARM

Model Number 380652-36

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 06/06/2018

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the unit for failure analysis, however, the failure analysis investigation has not been completed.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted once the investigation has been completed 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.

Event Description

It was reported that during a da vinci-assisted surgical procedure, a system error was experienced on arm 3 with the option to deactivate.There was no cannula installed but the error pointed to a magnetic cannula sensor error.Arm 3 was deactivated then the error occurred on arm 4 which gave the option to deactivate as well.Intuitive surgical, inc.(isi)technical support engineer (tse) requested the customer to remove the drapes and install the cannulas on both arms but the issue persisted.The customer tried using different cannulas and performed an emergency power off (epo) but once again, the issue persisted.At that time, the surgeon made the decision to convert and complete the procedure using laparoscopic techniques.There was no report of patient harm, adverse outcome or injury.Isi obtained the following information from the isi clinical sales representative (csr) about the complaint: the patient was administered anesthesia and the issue was identified during draping.An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The reported complaint was confirmed based on the field evaluation.The fse replaced universal side manipulators (usms) to resolve the issue.The system was tested and verified as ready for use.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received two universal surgical manipulators (usm) for evaluation.The failure analysis results are as follows: first usm, the reported failure could not be reproduced but was confirmed as having occurred via system logs.The unit passed normal mode and also passed cannula check, lissajous, sine cycle, cva characterization, friction speed low and friction speed high.The assembly was opened and found no signs of fluid intrusion or any issue that could generate the fault.The second usm, the reported failure was reproduced.The usm triggered the fault in normal mode.

• Brand Name: DAVINCI XI
• Type of Device: PATIENT SIDE CART, 4-ARM
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• MDR Report Key: 7648666
• MDR Text Key: 112892343
• Report Number: 2955842-2018-10326
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/06/2018

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: 380652-36
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Initial Date Manufacturer Received: 06/06/2018
• Initial Date FDA Received: 06/28/2018
• Supplement Dates Manufacturer Received: 07/03/2018
• Supplement Dates FDA Received: 07/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES