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

Model Number 380677-11

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2021

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.Fse confirmed the reported complaint.Fse replaced the master tool manipulator (mtm) gimbal assembly due to the physical damage.The system was tested and verified as ready for use.Isi received the unit involved with this complaint but analysis has not been completed.A follow-up mdr will be submitted if additional information is received.A review of the site's complaint history does not reveal any related complaints involving this product or this event.Intuitive surgical, inc.(isi) technical support engineer (tse) reviewed the system logs and found no related errors.No image or video clip for the reported event was submitted for review.This complaint is considered a reportable malfunction due to the following conclusion: system unavailability after start of a surgical procedure could lead to the procedure to be converted and may lead to an injury due to the patient¿s inability to tolerate a conversion.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.

Event Description

It was reported that during a da vinci-assisted sigmoid colectomy surgical procedure, the finger piece from the master tool manipulator (mtm) fell off.The surgeon used the instrument release kit (irk) to remove all instrument and elected to use another surgeon side console (ssc) for the procedure.The procedure continued robotically with no injury to the patient.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained additional information: the procedure was completed robotically using another surgeon side console (ssc) with no injury to the patient.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Corrected information can be found in the following field: e4.E4 was selected incorrectly as "yes".E4 is unknown.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Updated information can be found in the following fields: e4, g3, g6, h2, h3, h6, h10.D02 - intuitive surgical, inc.(isi) received the master tool manipulator (mtm) gimbal assembly involved with this complaint and completed the device evaluation.Failure analysis investigation reproduce the reported complaint during calibration via matlab.Worn out opto buttons were noted along axis 8/grip.The opto button assemblies will be replaced as a fix.

• Brand Name: DAVINCI XI
• Type of Device: SURGEON SIDE CONSOLE, SMART PEDALS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 13027933
• MDR Text Key: 287815170
• Report Number: 2955842-2021-11767
• 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: Other,Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380677-11
• Device Catalogue Number: 380677
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2017
• 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