MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; VISION SIDE SYSTEM

Model Number 381121-30

Device Problem Output Problem (3005)

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

Event Date 03/08/2022

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 fse confirmed and reproduced the reported failure and replaced the integrated electrosurgical unit (iesu) viodv generator.After replacement, the system and the iesu were tested as a unit, iesu operated as expected.The system was verified as ready for use.Isi received the iesu involved with this complaint; however, device evaluation remains ongoing.A supplemental report will be submitted once failure analysis has been completed or additional information has been 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 available for review.Verification via system logs confirmed the occurrence of a procedure on the reported event date matching the documented event details.No related error was identified through the system logs.No further review is required as the logs were reviewed/analyzed as part of the isi tse and isi fse's investigation this complaint is considered a reportable malfunction due to the following conclusion: the integrated electrosurgical unit (iesu) viodv generator was replaced after the start of the procedure and the surgeon was able to continue with the procedure robotically with a third-party esu.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.System unavailability after start of a surgical procedure could lead to the procedure to be converted/aborted and may lead to an injury due to the patient's inability to tolerate a procedure change.

Event Description

It was reported that during a da vinci-assisted gastrectomy (total) surgical procedure, an unspecified bipolar instrument was not recognized with the bottom port on the integrated electrosurgical unit (iesu) viodv generator.The customer received phone assistance from the technical support engineer (tse).Review of the site¿s system logs identified no related error.Upon verification, tse confirmed that a question mark prompt was displayed on the iesu generator.The other bipolar port on the iesu generator was working properly.The customer had performed a power cycle of the system and the iesu generator, replaced the instrument cable, and replaced the instrument but the issue persisted.Intuitive surgical, inc.(isi) followed up with the clinical sales representative (csr) and obtained the following additional information: system functionality was checked upon powering on the system.The iesu generator initially powered on without errors.The lower bipolar port could not be used during the procedure and the customer switched over to an external generator (activated through an external pedal) to continue the surgical task.The user continued with the procedure with no further issue reported.No known impact or patient consequence was reported.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the integrated electrosurgical unit (iesu) involved with this complaint and completed the device evaluation.Failure analysis s confirmed and reproduced the customer reported complaint.The iesu was placed on an in-house system and was run in an normal mode.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: DAVINCI XI
• Type of Device: VISION SIDE SYSTEM
• 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: 14048645
• MDR Text Key: 298471374
• Report Number: 2955842-2022-10933
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110898
• UDI-Public: (01)00886874110898
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/08/2022

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: 381121-30
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2022
• Initial Date Manufacturer Received: 03/08/2022
• Initial Date FDA Received: 04/07/2022
• Supplement Dates Manufacturer Received: 04/20/2022
• Supplement Dates FDA Received: 05/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2018
• 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.