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

Model Number 381121-39

Device Problem Output Problem (3005)

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

Event Date 03/31/2022

Event Type  malfunction  

Manufacturer Narrative

The technical service engineer (tse) advised the clinical sales representative (csr) to power cycle the erbe when possible.The field service engineer (fse) confirmed that the csr was able to power cycle the erbe to resolve the issue.No site visit was conducted.The system was working properly and no additional action was required.A review of the site's complaint history does not reveal any related or duplicate complaints involving this product and/or this event.Event verification: the tse verified the event upon troubleshooting with the customer.Rfe procedure review was performed.Per the review, the following was confirmed: an abdominoperineal resection procedure was performed on (b)(6) 2022 on system (b)(4).System log review: a review of the site's system logs for the reported procedure date was conducted by tse.Investigation revealed the following possible related system errors: iesu error: c-06 - system error.Activation request without parameter dataset.Iesu error: m-18 - internal timeout (cpu & sensors module does need too much time to enter "idle" state).Iesu error: m-11 - internal timeout (cpu & sensors module does need too much time to enter "ready" state).This complaint is considered a reportable event due to the following conclusion: the system was in an unacceptable state after the start of the procedure as the erbe had repeated errors.While the surgeon was able to continue with the procedure robotically with a backup generator, the reported issue could be indicative of a system functionality problem that results in the system being in an unacceptable state.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 conversion/abortion.

Event Description

It was reported that during a da vinci-assisted abdominoperineal resection surgical procedure, the clinical sales representative (csr) noted that the customer encountered repeated errors on the erbe, errors m-11, c-00 and c-06.The technical service engineer (tse) reviewed the logs and confirmed the errors.The tse recommended to power cycle the erbe.The csr was unable to power cycle the generator at the time but stated they would do so when able.The tse discussed how to connect a force triad generator.The procedure was completing as planned with no reported injury.Isi made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.

• 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: 14257327
• MDR Text Key: 290450738
• Report Number: 2955842-2022-11358
• 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: 03/31/2022

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: 381121-39
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/31/2022
• Initial Date FDA Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES