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

Model Number	380690-03
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2022
Type of Reportable Event	Malfunction
Additional 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 found intermittent error on the illuminator.The fse was unable to light up the lamp and replaced the illuminator to resolve the issue.The system was tested and verified as ready for use.Isi has requested the illuminator involved with this complaint be returned but it has not been received yet.Therefore, the root cause of the alleged customer reported failure mode has not been determined.A follow-up mdr will be submitted upon completion of the failure analysis evaluation and if additional information is received.No image or video was available for review.A review of the site's system logs for the reported procedure date was conducted by technical support when the customer called for troubleshooting assistance.Investigation revealed error 48245 related to the reported complaint.An event verification confirmed the procedure was performed on the reported event date (b)(6) 2022 on system (b)(4).This complaint is considered a reportable malfunction due to the following conclusion: the illuminator was replaced after the start of the procedure and the surgeon was able to continue with the procedure robotically third-party illuminator.While there was no harm or injury to the patient, 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.Follow-up was attempted, but the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The product is not implantable.Insufficient product information was provided in order to obtain the date of manufacture.
Event or Problem Description
It was reported that during a da vinci-assisted prostatectomy surgical procedure, the system received the message "illuminator lamp module not found and to reseat lamp module".An isi clinical sales engineer (cse) guided the customer to reseat the lamp module.An isi technical support engineer (tse) reviewed the system logs and found error 48245 reported repeatedly and the customer recovered the error each time.The procedure was completed with no reported injury.Isi followed up with the initial reporter and obtained the following additional information on 12-oct-2022: the reported issue occurred during procedure.The system functionality was checked upon powering on the system and the illuminator initially powered on without errors.The issue was resolved by reseating the lamp module.The procedure was completed robotically.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the illuminator involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation could not reproduce the customer-reported complaint.However, the error/fault was confirmed via error logs/system logs.The illuminator was returned with a lamp module, and both fuses were good.When reviewing the remote error log, there are several errors: 48245 means the illuminator lamp failed to ignite after several automatic attempts.After this error, ignite attempts stop and the lamp remains off until the user tries to switch the lamp on again.An ignition failures indicate that the lamp module must be replaced or the ignition circuitry in the illuminator has failed.Error 48244 means illuminator lamp failed to ignite indicate that the lamp module is nearing end of life or the ignition circuitry in the illuminator is failing.An error 48247 means the illuminator is unable to communicate with its lamp module or finds an invalid lamp module (due to invalid/corrupted id or encryption data), lamp hours may be accumulated incorrectly.Replacement of the lamp module is recommended.Fa installed the illuminator into a test system with the test fixture lamp module, and the system started up without error, the illuminator turn on with blue led, and all the vision tests passed.Fa verified all video ports, which balance and 3d tests passed.The image was good with and without turning on the light.Fa booted up system in normal mode and let it idle for 10 minutes.Fa power cycled system 30 times, no issues occurred after extensive use.

• Brand Name: DAVINCI SI
• Common Device Name: VISION SIDE SYSTEM, RECERTIFIED
• 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: 15741505
• Report Number: 2955842-2022-15122
• Device Sequence Number: 5850428
• Product Code: NAY
• UDI-Device Identifier: 00886874110799
• UDI-Public: (01)00886874110799
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K081137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2022

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
• Operator of Device: Health Professional
• Device Model Number: 380690-03
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2022
• Supplement Date Received by Manufacturer: 12/22/2022
• Initial Report FDA Received Date: 11/06/2022
• Supplement Report FDA Received Date: 01/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian