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

Model Number	430077-05
Medical Device Problem Code	Image Orientation Incorrect (1305)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did not receive the da vinci product with an alleged issue to perform failure analysis.Failure analysis found the primary finding of camera instrument, endoscope shaft damage to be related to the customer reported complaint.The camera was found to have shaft mechanical damage.The distal main tube was found to be bent inward in multiple places.Despite the damage on the distal main tube, the endoscope was still fully functional.Although the mechanical shaft was damaged, the qap (quality assurance procedure) could still be performed on the in-house system.Functional tests were performed and passed.Stereo calibration, endoscope focus test and color recognition was performed and passed.Images were clear de-warped and not grainy.No noise or motion blur was seen.The buttons were fully functional and moved intuitively.First endoscope digital test (edt) testing passed.The review of logs showed no errors found within 3 months of return create date.Leak tests were performed and passed.Probable root cause is attributed to the defective camera.
Event or Problem Description
It was reported that the endoscope metal end was jammed and was not moving correctly.There was no report of patient injury or harm.Intuitive followed up but customer did not have additional 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: 24470594
• Report Number: 2955842-2026-06356
• Device Sequence Number: 16021795
• Product Code: NAY
• UDI-Device Identifier: 00886874122228
• UDI-Public: (01)00886874122228
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/27/2026

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?: 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: 02/18/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2025
• 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
• Patient Sex: Unknown