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

Model Number	430077-05
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) requested that the endoscope be returned for failure analysis investigation.Isi has not received the da vinci product with an alleged issue to perform failure analysis.
Event or Problem Description
It was reported that during a da vinci-assisted prostatectomy - radical extraperitoneal w/ lymphadenectomy surgical procedure, a fluid leaks at the distal end of the endoscope.There is no report of involved procedure.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The endoscope was analyzed and the camera was installed on in-house system and passed engagement, recognition, and initialization.The camera passed self-test on in-house system.The camera was found to have no error message generated and no noise and no imaging issues.The qap (quality assurance procedure) was performed and was able to recognize all different images and targets in 80mm and 20mm distances with no issue.There was no ghosting observed when switching from different targets.The endoscope light intensity, brightness or luminance was found in good level for visualization.Performed the firefly test with no issue.Note: the endoscope passed air leak test with no bubble/s observed.The 1st, and 2nd edt tests passed with no issue.Borescope inspection showed no punctures/tears on the manifold membrane.Scope error finder review showed no error.
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: 20607201
• Report Number: 2955842-2024-21552
• Device Sequence Number: 8144690
• Product Code: NAY
• UDI-Device Identifier: 00886874122228
• UDI-Public: (01)00886874122228
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2024

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2024
• Supplement Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2024
• 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: 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: Prefer Not To Disclose