MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; SURGEON SIDE CONSOLE, SMART PEDALS

Model Number 380677-17

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 08/06/2020

Event Type  malfunction  

Manufacturer Narrative

An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The surgeon stopped getting response from the mtmr and error 25521 occurred.The fse replaced the mtmr to resolve the issue.The system was tested and verified as ready for use.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 side console (ssc).One mtm is assigned to the surgeons' left hand (mtml) and one to the right (mtmr).Isi received the mtmr involved with this complaint and completed the device evaluation.Failure analysis investigation was able to reproduce the reported failure (error 25521) during sine cycle.Additional findings: during evaluation, the opto button pads and the gimbal grip pads were found to be worn out.A review of the site's complaint history does not show any additional complaints related to this product.No image or video clip for the reported event was submitted for review.The isi technical support engineer (tse) reviewed the logs and confirmed the error 25521 when the customer contacted technical support.Based on the information provided at this time, this complaint is being classified as a reportable malfunction event due to the following conclusion: the error 25521 related to the mtmr appeared on the system despite troubleshooting attempts to resolve the issue.System unavailability after the start of a surgical procedure (first port incision) contributed to the procedure being converted to a laparoscopic procedure.Although there was no patient harm reported as a result of this event, if the issue were to recur it could cause or contribute to an adverse event.

Event Description

It was reported that during a da vinci-assisted sigmoid colectomy surgical procedure, error 25521 on right master tool manipulator (mtmr) was observed.The site power cycled prior to calling the technical support engineer (tse) and the error came back as a hard fault.The tse had the site back drive the mtmr and power down and cycle the surgeon side console (ssc) breaker and power back on.The system faulted within seconds of the surgeon taking control of the right master.The surgeon said he was enough through the case that he could finish laparoscopically.Site was in the process of converting when the call with the tse ended.The procedure was completed laparoscopically with no reported injury.

• Brand Name: DAVINCI XI
• Type of Device: SURGEON SIDE CONSOLE, SMART PEDALS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 10475266
• MDR Text Key: 231684858
• Report Number: 2955842-2020-10842
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110744
• UDI-Public: (01)00886874110744
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/06/2020

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: 380677-17
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 08/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1