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

Model Number 380677-23

Device Problem Visual Prompts will not Clear (2281)

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

Event Date 03/31/2022

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The fse was able to reproduce the reported problem.The fse reviewed the system log and identified error 23025 pointing to axis 4 of the right master tool manipulator (mtm) on surgeon side console (ssc) 1.The fse replaced the right mtm and performed a test drive.The system was tested and verified as ready for use.Intuitive surgical, inc.(isi) received the mtm involved with this complaint and completed the device evaluation.Failure analysis investigations reproduced the reported failure/error during the system power-up.The axis 4 motor and motor cable would be replaced as a fix.Fse reviewed the logs and confirmed the reported error.In addition, a review of the site's complaint history identified no other complaints related to this reported event.No image or video clip for the reported event was submitted to isi for review.This complaint is being reported due to the following conclusion: system unavailability after the start of a surgical procedure (first port incision) contributed to the procedure being converted to another da vinci surgical system.Although there was no patient harm reported, if the alleged malfunction were to recur it could cause or contribute to an adverse event.

Event Description

It was reported that during a da vinci-assisted bladder augmentation surgical procedure, the site encountered error 23025 on a surgeon side console (ssc).The site rebooted the system, but error 23025 was not resolved.The site elected to use their other ssc to continue with the case.The technical support engineer (tse) attempted to review the system logs, but the customer was not in the operating room at the time of the call to perform troubleshooting.The procedure was converted to another da vinci surgical system with no reported injury.On 11-apr-2022, intuitive surgical, inc.(isi) performed follow-up and obtained the following additional information regarding the reported event: system functionality was checked prior to use, and no issues/errors were noted.However, error 23025 occurred on ssc 1 during the procedure.The surgeon converted to ssc 2 and completed the procedure successfully.

• 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: 14251776
• MDR Text Key: 290530607
• Report Number: 2955842-2022-11329
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110744
• UDI-Public: (01)00886874110744
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380677-23
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2021
• 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
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Race: Asian