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

Model Number 380677-21

Device Problems Use of Device Problem (1670); Defective Component (2292)

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

Event Date 11/09/2020

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 fse identified the magnet inside the master tool manipulator left (mtml) fell out which caused the grip axis to not work.The mtml was replaced, and the system was tested and verified as ready for use.Isi received the mtml involved with this complaint and completed the device evaluation.Failure analysis investigation confirmed the reported failure and was able to reproduce it during power up.A system log review was conducted and errors related to the left mtm were found.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.No image or video clip of the reported event was submitted for review.Based on the information provided at this time, this complaint is being reported due to the following conclusion: the mtml of the surgeon side console did not function as expected.System unavailability after start of a surgical procedure (first port incision) could lead to the procedure to be converted/aborted.While there was no harm or injury to patient, the reported failure mode could cause or contribute to an adverse event if it were to recur.

Event Description

It was reported that during a da vinci-assisted myomectomy surgical procedure, the surgeon was unable to control an unspecified instrument installed on arm1 and arm 2.Reportedly, the surgeon could not control the master tool manipulator left (mtml).The procedure was converted to laparoscopic surgery with no reported injury.Intuitive surgical, inc.(isi) followed up with the operating room (or) nurse and obtained the following additional information: system functionality was checked upon powering on the system.The system initially powered on without any errors.The procedure was completed laparoscopically with no injury or harm to the patient.The surgeon believed the mtm had the problems since he was unable to control it.The surgical staff did not observe any outside influences that were impeding the movement of the system.The issue occurred during the middle of the surgery.The patient did not experience any post-operative complications.No video recording or photo images of the procedure were available for review.

• 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: 10939522
• MDR Text Key: 219377146
• Report Number: 2955842-2020-11294
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110744
• UDI-Public: (01)00886874110744
• Combination Product (y/n): N
• Reporter Country Code: KR
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/09/2020

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: 380677-21
• Device Catalogue Number: 380677
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2020
• Initial Date FDA Received: 12/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2020
• 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
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES