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

Model Number	380690-03
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	05/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported event.Fse replaced illuminator to resolve the issue.The system was verified and ready to use.Isi has not received the device for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.
Event or Problem Description
It was reported that during a da vinci-assisted malignant hysterectomy surgical procedure, the customer called the technical support engineer (tse) and stated that there was a recoverable 45310 fault.The instrument had grasped the tissue and the tse suggested that they release the tissue by using the instrument release key (irk).They confirmed tissue release by using the irk.The tse suggested that they reboot the system.It was confirmed error 297 after reboot.The tse reviewed logs and told them that the illuminator needed to be replaced.The procedure was converted to open surgery with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the case was converted to open surgery due to loss of vision as the light source on the camera was not functional.There was a system malfunction intra-operatively and troubleshooting was performed with the da vinci surgery technical assistance team (dvstat).The patient was not harmed because of the malfunction.The loss of light source from the camera resulted in a malfunction which led to loss of vision during the procedure.The system was inspected prior to the case and the procedure progressed for 20 minutes before the malfunction.No post-operative complications occurred to the patient.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
The illuminator was returned for failure analysis and the reported failure was replicated.The unit was installed on an in-house system and was unable to power up with an error.

• Brand Name: DAVINCI SI
• Common Device Name: VISION SIDE SYSTEM, RECERTIFIED
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 19562907
• Report Number: 2955842-2024-15806
• Device Sequence Number: 7680824
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 05/20/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 07/22/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female