MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI; SURGEON SIDE CONSOLE

Model Number 380610-14

Device Problem No Display/Image (1183)

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

Event Date 12/03/2021

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.The left screen in the high resolution stereo viewer (hrsv) of surgeon side console 1 was replaced to resolve the issue of black image during surgery.The system was tested and verified as ready for use.Isi has not yet received the replaced component for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.A review of the site's complaint history does not show any additional complaints related to this product.No image or procedure video was provided.Fse reviewed the system logs at the time of the call into technical support.The logs confirmed the reported errors.This complaint is being reported based on the following conclusion: system unavailability after the start of a surgical procedure caused the procedure to be converted to another da vinci and may lead to an injury due to the patient¿s inability to tolerate a conversion/abortion.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.Blank mdr fields: follow-up was attempted, but the missing patient information in sections was either unknown, unavailable, not provided, or not applicable.The expiration date for section is not applicable.Field is blank because the product is not implantable.Information for the blank fields in section is not available.Fields are not applicable.

Event Description

It was reported that during a da vinci assisted prostatectomy surgical procedure, there was no signal on one eye of surgeon side console (ssc) 1.The caller (doctor) indicated the display was fine on ssc 2.Due to the surgery being in progress, the surgeon did not want to troubleshoot the issue.Intuitive surgical inc.(isi) technical support engineer (tse) could not view live system logs.The procedure was completed with no patient injury.Additional information was obtained on 07-dec-2021.The tse reviewed system logs and confirmed that surgeon side console (ssc) 2 was used to complete the procedure.The isi field service engineer (fse) confirmed that the ssc1 was down during the surgery and a switch to ssc 2 was required to complete the procedure.

Manufacturer Narrative

D14- intuitive surgical, inc.(isi) has received the hrsv (high resolution stereo viewer) associated with this complaint and completed investigations.Failure analysis investigations could not replicate nor confirm the customer reported complaint.When the hrsv was installed on an in-house system and powered on, video was seen on both eyes of the surgeon side console.The unit ran through a series of power cycles and burn-in for multiple hours and no issues were observed.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: DAVINCI SI
• Type of Device: SURGEON SIDE CONSOLE
• 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: 13101747
• MDR Text Key: 285412569
• Report Number: 2955842-2021-11824
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110683
• UDI-Public: (01)00886874110683
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K081137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380610-14
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2012
• 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 Sex: Male