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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after a da vinci-assisted ovarian cystectomy surgical procedure, there was an issue with the single port (sp) camera instrument's focusing not being correct.After the surgery, and after cleaning was completed, a camera was connected for da vinci sp practice, but the endoscope self-test failed.A message saying "clean connector or replace endoscope" appeared, making it unusable.No fragment fell into the patient.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
The single port (sp) camera instrument has been returned and evaluated by the failure analysis (fa) team.Fa investigations could neither replicate nor confirm the customer-reported complaint of 'self-test failed' nor verify an external event to be related.The endoscope was tested and placed on an 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 and no noise or motion blur was seen.The buttons were fully functional and moved intuitively.The manifold membrane was inspected with the borescope probe, and no punctures or tears were found.There was no problem detected.Additionally, the endoscope was visually inspected and found with mechanical damage to the scope¿s distal tip.The camera was found to be missing a piece of the endoscope tip.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
The probable root cause of the customer reported issue cannot be determined as the issue was not confirmed nor replicated in the failure analysis.The probable root cause of the vision other component is attributed to user, such as inadvertent collisions with hard surfaces or drop of the scope.

• 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: 23690517
• Report Number: 2955842-2025-47069
• Device Sequence Number: 21426430
• Product Code: NAY
• UDI-Device Identifier: 00886874122228
• UDI-Public: (01)00886874122228(11)241206
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K212101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

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?: Yes
• 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: 06/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/24/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2024
• 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
• Patient Sex: Female