MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SP; CAMERA, 0°

Model Number	430077
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	11/03/2025
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.Based on the field evaluation, this reported event was confirmed.The system generated an error, and the endoscope could not display images.Endoscopes with serial numbers (b)(6) generated an error message after being connected to the system and failed the self-test.Using a spare endoscope resolved the issue.The endoscopes with these serial numbers were tested on the training system at the training center and the same fault occurred.The training endoscope worked normally, so this is called a repair endoscope fault.It is recommended to replace the endoscope to eliminate this abnormality.The system was tested and verified as ready for use.Isi did not receive the product for failure analysis evaluation.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, the customer encountered a self-test failure on two endoscopes when they were connected to the endoscope controller (ec).The technical service engineer (tse) reviewed the system logs and found errors on the ec and endoscopes (b)(6).The tse had the customer clean the endoscope connectors, hard power cycle, and reseat the cables, but the issue persisted.The customer converted the case from single port to laparoscopy.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the customer confirmed that the ports were placed when the issue occurred.It was confirmed that the ports were not increased and the patient tolerated the conversion from single port to traditional laparoscopy without issue.

• Brand Name: ENDOWRIST SP
• Common Device Name: CAMERA, 0°
• 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: 23688346
• Report Number: 2955842-2025-46590
• Device Sequence Number: 13118831
• Product Code: IZI
• UDI-Device Identifier: 00886874122228
• UDI-Public: (01)00886874122228
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K212101
• 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
• Report Date (Section B): 12/01/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 430077
• Device Catalogue Number: 430077
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/19/2025
• 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: Initial
• 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: Unknown