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	02/09/2023
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 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 reportable malfunction event due to the following: it was alleged that the light source was not getting turn on during procedure.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.
Event or Problem Description
It was reported that during a da vinci-assisted nephrectomy surgical procedure, the light source was not getting turn on through camera head/light source once they turn off it.Intuitive surgical, inc.(isi) technical support engineer (tse) checked the logs and confirmed an error 48245 on the illuminator.The customer confirmed that the lamp module was replaced for the same issue previously.The procedure was completed with no reported injury.Isi followed up with the initial reporter and obtained the following additional information: the system functionality was checked upon powering on the system and there were no error on initial bootup.The customer recovered the error to proceed.There was no patient injury and the procedure was completed robotically.
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/confirmed the customer reported complaint.In house fa installed illuminator into printed circuit assembly (pca) system and failed to power up with error 48245 which means illuminator lamp failed to ignite.Fa performed visual inspection with 0 bad fuses.The illuminator had a dusty fan and no lamp module inside.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• 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: 16483450
• Report Number: 2955842-2023-11076
• Device Sequence Number: 17458677
• 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: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2023

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: 02/09/2023
• Supplement Date Received by Manufacturer: 05/01/2023
• Initial Report FDA Received Date: 03/04/2023
• Supplement Report FDA Received Date: 05/30/2023
• 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