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

Model Number	430077-05
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	11/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted low anterior resection procedure, vision went blurry, then lines appeared on the screen, and the screen went red, then it went to black.The procedure was converted to an open approach.The surgeon extended the sp incision to open, partially due to the endoscope issue.The procedure was converted to open due to lack of progress and unclear anatomy; it was not anticipated, but not unusual in these cases.He stated that the procedure could not have been converted to laparoscopic or completed robotically because of the patient¿s anatomy.Specifically, the patient had dense adhesions and was overall in poor condition.The patient also had inflamed anatomy and strictures.Technical support was not called.A backup endoscope was available; however, the surgeon converted to open for the reasons stated above.The impact on the patient¿s health was limited to requiring a longer incision, and there was no concern for long-term complications.The patient did not experience any post-operative complications and has since been discharged.
Additional Manufacturer Narrative
An intuitive surgical, inc.(isi) product has been received a for failure analysis evaluation.However the failure analysis investigation has not been completed at the time of this report.
Additional Manufacturer Narrative
Updated fields: h2, h3, h6, and h11.Device evaluation: the endoscope was received and failure analysis found the camera to have communication failures based off log review but was not replicated during in-house testing.A review of the logs showed 8 communications errors.The endoscope was tested and placed on in-house system or equivalent for functional testing and passed.Stereo calibration, endoscope focus test and color recognition were performed and passed.Images were clear, dewarped and not grainy.No noise or motion blur was seen.The buttons were fully functional and moved intuitively.First edt testing passed.Leak tests were performed and passed.The manifold membrane was inspected with the borescope probe and no punctures or tears were found.
Event or Problem Description
Refer to h11 for follow-up information.

• 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: 23816308
• Report Number: 2955842-2025-48637
• Device Sequence Number: 21323041
• Product Code: IZI
• UDI-Device Identifier: 00886874122228
• UDI-Public: (01)00886874122228
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K212101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2026

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: 430077-05
• Device Catalogue Number: 430077
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2025
• 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: 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: Unknown