MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SP; CAMERA, ZERO DEGREE

Model Number	430077-05
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the da vinci product with an alleged issue to perform failure analysis.Failure analysis found the primary finding of endoscope mechanical shaft damage to be related to the customer reported complaint.The reported issue with the endoscope of mechanical shaft damage was confirmed.The endoscope shaft mechanical damage was 75mm from the distal tip.The shaft damage encompassed the entire circumference of the shaft, limiting the endoscopes imprecise range of motion.A visual inspection for shaft damage such as bends, dents, or deep scratches was performed and failed.The endoscope mechanical shaft damage was inspected with the naked eye and likely caused a dislodged disc.The endoscope was placed on the in-house edt tester and passed.The qap (quality assurance procedure) was performed and failed the functional test for imprecise motion, although there were no other issues observe focus test, endoscope recognition, stereo calibration, firefly and color recognition testing passed.The range of motion for joggle and wrist was tested pointing at the in-house target and moving to all 4 corners of the joggle pitch and yaw range of motion and failed.The endoscope failed to move into the cobra position when operating the sc., the video was free of the reported fogging complaint however the joggle and wrist did not have full range of motion likely due to the endoscope mechanical shaft damage and dislodged disc.A review of logs showed error code 48221 communication error and 282 system tool invalid error.The leak test was performed and passed.The endoscope passed visual inspection of the manifold membrane.The endoscope was found to have a dislodged disc 75mm from the distal tip.The dislodged disc limited the endoscopes imprecise range of motion.A visual inspection for instrument cable inspection for dislodged discs was performed and failed.The endoscope's dislodged disc was inspected with the naked eye and failed likely due to the endoscope mechanical shaft damage.The probable root cause is attributed to damage during use or improper handling, which may include accidental drops of the endoscope or inadvertent collisions with hard surfaces.This issue can be resolved by using an alternate endoscope to complete the procedure.
Event or Problem Description
It was reported that the endoscope was broken at the articulating joint.Intuitive followed up with the initial reporter and obtained the following additional information: the customer has no additional information.

• Brand Name: ENDOWRIST SP
• Common Device Name: CAMERA, ZERO DEGREE
• 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: 24285482
• Report Number: 2955842-2026-03673
• Device Sequence Number: 13252479
• Product Code: NAY
• UDI-Device Identifier: 00886874122228
• UDI-Public: (01)00886874122228
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/06/2026

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: 01/29/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 02/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2025
• 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