MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; VISION SIDE SYSTEM

Model Number 381121-36

Device Problems Defective Component (2292); Device Displays Incorrect Message (2591)

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

Event Date 07/21/2020

Event Type  malfunction  

Manufacturer Narrative

An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The fse replaced the personality module video/ auxiliary (pmva) to resolve the system issue.The system was tested and verified as ready for use.Intuitive surgical, inc.(isi) received the pmva involved with this complaint and completed the device evaluation.Failure analysis investigations replicated/confirmed the customer reported complaint.The pmva was installed on the test system and it failed with error 307 on startup.The system could not detect the module and the video branch (vbr) had failed.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.This complaint is reportable due to the following: it was reported that during a da vinci-assisted surgical procedure, the customer experienced overheating faults on the system.Troubleshooting was performed, but the system faults continued to appear.System unavailability after the start of a surgical procedure (first port incision) contributed to the procedure being converted to laparoscopy.Although there was no patient injury reported, if the failure were to recur, it could cause or contribute to an adverse event.

Event Description

It was reported that during a da vinci-assisted total benign hysterectomy surgical procedure, the customer experienced overheating faults on the system.The technical support engineer (tse) had the customer check for dust buildup and to open the backdoor for better ventilation.The customer had power cycled the system but proceeded to get error 307.The issue persisted after a second power cycle.The customer then chose to convert to laparoscopy.The customer later called back to further report that the robot had overheated and shut off.The tse reviewed error logs and found error 90 and error 92 pointing to the personality module video/ auxiliary (pmva).The tse requested that the customer check for obstructions to airflow and the customer identified dust on the filters behind the cosmetic covers.The system was, again, powered on, but error 307 appeared again.The customer was unable to troubleshoot further.The case was continuing laparoscopically.Intuitive surgical, inc.(isi) followed up with the customer to confirm that the procedure was completed after converting to laparoscopy.The customer had performed troubleshooting but the issue persisted.The surgeon chose to convert to laparoscopy to finish the procedure.There was no patient harm and no post-operative complications.The system was normal during setup and only experienced overheating during the case.No video of procedure was available.There was no patient demographic information available other than gender.

• Brand Name: DAVINCI XI
• Type of Device: VISION SIDE SYSTEM
• 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: 10411265
• MDR Text Key: 243723453
• Report Number: 2955842-2020-10748
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110898
• UDI-Public: (01)00886874110898
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/21/2020

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: 381121-36
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2020
• Initial Date FDA Received: 08/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1