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

Model Number 380610-20

Device Problems Defective Component (2292); Device Displays Incorrect Message (2591)

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

Event Date 04/09/2020

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 reported complaint was not reproduced during field evaluation.The fse identified that the problem came from the embedded serializer in master base (esmb)2 of the right mtm.The mtm was replaced due to errors 25520 and 707.The system was tested and verified as ready for use.Isi has not received the mtm for failure analysis investigation.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 and/or this event.No image or video clip for the reported event was submitted for review.A review of the system logs was conducted.The logs indicate that the system error occurred prior to the start of the procedure.Technical review of the specific error was performed by the fse while troubleshooting the reported issue and determining the resolution.Based on the information provided at this time, this complaint is being reported due to the following conclusion: a da vinci system malfunction occurred, rendering the da vinci system unavailable for use after the reported start of a surgical procedure.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 a da vinci-assisted partial nephrectomy surgical procedure, a non-recoverable error 25520 occurred and the leds on the arms were yellow.The right master tool manipulator (mtm) was inoperable.The technical service engineer (tse) had the customer perform a power cycle on the system with no resolution.The tse guided the customer to switch to the other surgeon side console (ssc).The procedure continued as planned with no reported patient harm, adverse outcome, or injury.Intuitive surgical, inc.(isi) followed up with the customer and obtained the following additional information: the system was powered on before the patient was placed under anesthesia.The patient¿s current status was good.The hospital discharged the patient one week after the procedure.

Manufacturer Narrative

Additional information can be found in the following sections: d10, g4, g7, h2, h3, h6 and h10.4307 - intuitive surgical, inc.(isi) received the master tool manipulator (mtm) involved with this complaint and completed the device evaluation.The reported complaint was reproduced during failure analysis during calibration via matlab.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Additional information can be found in the following fields: g4, g7, h2 corrected information can be found in the following fields: d4, g5 field d4 (model number) has corrected information (product sequence number only) - updated from 380610-21 to 380610-20.Field g5 (pma/510k number) was blank on the initial mdr and has been obtained: "k081137".

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: 10020976
• MDR Text Key: 189745737
• Report Number: 2955842-2020-10459
• 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: foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380610-20
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2020
• Date Manufacturer Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.; DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Age: 46 YR
• Patient Weight: 65