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	02/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the claim against the product by the customer noting error 48245, an investigation is in progress 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 system received an error 48245 while turning on the illuminator.The fse tried to power on the illuminator from itself, then from camera head, and then from the surgeon side console (ssc) but it was not working.So, the fse had reset the lamp module and changed the new lamp module from customer, but the issue persisted.The fse replaced the illuminator to resolve the reported issue.The system was tested and verified as ready for use.Isi did not receive a da vinci product involved with this complaint to perform failure analysis.Additional information is being gathered to determine the contribution of the device to the customer reported issue.This complaint is considered a reportable malfunction event due to the following conclusion: it was alleged that the system had error 48245 is showing on system while turning on illuminator during procedure.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 procedure change.
Event or Problem Description
It was reported that during a da vinci-assisted nephrectomy surgical procedure, the system had error 48245 showing on the system while turning on illuminator.Intuitive surgical, inc.(isi) technical support engineer (tse) checked the system logs and confirmed the error.The tse informed that the illuminator and lamp module were already replaced.The procedure was completed with no reported injury.Isi followed up with the initial reporter and obtained the following additional information: the reported issue occurred during procedure.The system functionality was checked and the system booted up with no error.The illuminator initially powered on without errors.As this was an intermittent issue, the customer recovered the error to complete the procedure.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
An intuitive surgical, inc.(isi) has received the illuminator involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation replicated the customer reported complaint.In house fa installed and configured on the test system.Upon power on, the illuminator failed with error 48245.The illuminator was unable to turn on the light.Fans were dusty and had sticky residue on the power receptacle.

• 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: 16580405
• Report Number: 2955842-2023-11409
• Device Sequence Number: 4747509
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2023

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: 380690
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2023
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 06/09/2023
• 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: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian