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

Model Number 380610-21

Device Problem Poor Quality Image (1408)

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

Event Date 08/25/2020

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) followed up with the fse and obtained the following additional information: no errors occurred during system power up, system functionality, and vision was checked after power up.The fse confirmed no errors occurred in the log files and full troubleshooting was completed.After docking, the surgeon immediately found the right eye was black with no errors; however, the surgeon went into following mode with only left eye vision.Since the right monitor did no function, 2d vision was not available.No patient injury was reported.The hrsv has not been returned to isi for evaluation.The root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if the instrument is returned (post engineering evaluation) or if additional information is received.Based on the information provided at this time, this complaint is being reported because system unavailability after start of a surgical procedure (first port incision) contributed to the procedure being aborted.Although no patient harm occurred, if this malfunction were to recur it could potentially cause or contribute to an adverse event.

Event Description

It was reported that during an unspecified da vinci-assisted prostatectomy surgical procedure, the surgeon side console (ssc) right eye was black right after docking the patient side cart to the patient.A field service engineer (fse) was able to isolate the issue to the ssc right monitor.The surgeon made the decision to abort the procedure post anesthesia and port placement with no reported injury.

Manufacturer Narrative

4307- intuitive surgical, inc.(isi) received the high resolution stereo viewer monitor involved with this complaint and completed the device evaluation.Failure analysis found the luminance was out of specification as there was no image in the input fiber optic.

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 95051
• MDR Report Key: 10547927
• MDR Text Key: 207405068
• Report Number: 2955842-2020-10921
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110683
• UDI-Public: (01)00886874110683
• Combination Product (y/n): N
• PMA/PMN Number: K081137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/25/2020

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: 380610-21
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Initial Date Manufacturer Received: 08/25/2020
• Initial Date FDA Received: 09/17/2020
• Supplement Dates Manufacturer Received: 12/28/2020
• Supplement Dates FDA Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.; DA VINCI INSTRUMENTS AND ACCESSORIES