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

Model Number	430077-05
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/12/2026
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.The missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Field e4 is blank because it is unknown if the initial reporter submitted a report to the fda.Fields g5 and g7 are not applicable.Field h10 is blank as there are no related report numbers.
Event or Problem Description
It was reported that after a da vinci-assisted surgical procedure, single port (sp) firefly endoscope had a broken seal.The procedure was completed using a backup endoscope and it is unknown if any fragments fell into the patient.The procedure was completed with no reported injury.Intuitive followed up but no additional information was available.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.Failure analysis found the primary finding of shaft damage to be related to the customer reported complaint.The endoscope was found to have a damaged distal main tube.Visual inspection was performed and found a slightly flared up distal main tube, right underneath the 1st disc of the endoscope.The customer complaint was confirmed.As a result of the flared distal main tube, the disc was found to be dislodged.The damage main tube likely caused the dislodged disc and imprecise motion failure.Cable zone a, b, and c was inspected and no tears or torn was observed.The manifold membrane was inspected with an in-house borescope, and no indentation or stain was observed on the camera membrane.The cobra was found to have a dislodged disc.Visual inspection was performed and found disc 1 slightly dislodged.When manually articulating the instrument cable, it was observed that disc 1 did not clamp into its groves properly likely due to the damaged distal main tube.Additionally, disc 7 also observed dislodged as well after manual articulation, disk 7 was slightly separated from disc 6.The dislodged disc likely caused imprecise motion failure.The endoscope was found to have an imprecise motion failure.The endoscope was placed on an in-house system for functional testing and failed one of the qap (quality assurance procedures) criteria.The endoscope was tested for its range of motion and observed a limited motion when articulating the endoscope on the system, likely due to this dislodged distal disc.The endoscope observed clear images, led light was turned on, and there were no pixels or artifacts observed during testing.Firefly mode was activated and passed.A review of customer logs found no error code within the last 30 days of the return create date.1st endoscope test (edt) was performed in-house and passed with no problem detected.The endoscope was placed on an in-house air leak test bathtub and both the distal and proximal leak test passed.140-180 mmhg of air pressure was applied and 30 seconds passed with the air pressure still within the limitation.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
Refer to h11 for follow-up information.

• Brand Name: ENDOWRIST SP
• Common Device Name: CAMERA, 0 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: 24243366
• Report Number: 2955842-2026-03048
• Device Sequence Number: 8327380
• Product Code: NAY
• UDI-Device Identifier: 00886874122228
• UDI-Public: (01)00886874122228
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 03/09/2026

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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2025
• 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