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

Model Number 381121-33

Device Problem Loss of Power (1475)

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

Event Date 05/03/2023

Event Type  malfunction  

Manufacturer Narrative

Based on the claim against the product by the customer noting iesu lost power, an investigation was completed to determine the cause of this reported event.An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported event.The fse replaced the iesu.The system was tested and verified as ready for use.Isi did receive a da vinci product involved with this complaint to perform failure analysis.The iesu was analyzed, and failure analysis confirmed and reproduced the failure.The complaint regarding iesu lost power was confirmed based on failure analysis, which indicates that the device did contribute to the customer reported issue.This complaint is considered a reportable event due to the following conclusion: the customer switch to the third-party generator to after the start of the procedure due to iesu not functioning.While there was no harm or injury to the patient, system unavailability after the start of a surgical procedure could likely cause or contribute to an adverse event if it were to recur as it may lead to an injury due to the patient¿s inability to tolerate a conversion/abortion.

Event Description

It was reported that during a da vinci-assisted radical with lymphadenectomy prostatectomy surgical procedure, the integrated electrosurgical unit (iesu) lost power and would not power back up.The intuitive surgical, inc.(isi) technical support engineer (tse) had the customer check that the power cord was fully seated in the wall outlet and on the back of the erbe.The customer confirmed that it was.The tse had the customer try another known good outlet; however, the issue persisted.The tse asked the customer if they had a force triad generator, and they did.The tse assisted the customer with connecting the generator, and they were able to continue with the procedure.The procedure was completing as planned with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the isi clinical sales representative informed that the case was completed robotically with the third-party generator.There was no injury to the patient.The patient demographics was provided.

• 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: 17007563
• MDR Text Key: 316721915
• Report Number: 2955842-2023-14585
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110898
• UDI-Public: (01)00886874110898
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 381121-33
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2023
• Date Manufacturer Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2019
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 85 KG