MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI; PATIENT SIDE CART, RECERTIFIED

Model Number	380686-04
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported event.The fse replaced the endoscopic camera manipulator (ecm) to resolve the issue.The system was tested and verified as ready for use.Isi did not receive a da vinci product involved with this complaint to perform failure analysis.The complaint was confirmed based on the field evaluation.
Event or Problem Description
It was reported that during a da vinci-assisted left hemicolectomy surgical procedure, user informed the technical support engineer (tse) that there was a patient side cart (psc) axes controller motor (acm) arm movement issue, specifically that the ecm arm became stuck and produced noise during pitch movement, while the other arms remained functional.The user attempted a power cycle which did not resolve the issue, and it was confirmed that no error was logged for the problem.The user converted to a laparoscopic approach to continue with the procedure.A procedure delay was reported.
Additional Manufacturer Narrative
Intuitive surgical inc.(isi) received the endoscopic camera manipulator (ecm) for failure analysis investigation.The unit was analyzed and was installed onto a known good system where no faults occurred in normal mode, but when clutched the insertion would click, replicating the reported event.Visual inspection found the rolling loop, flat flex cables (ffcs) to be bent and warped.The complaint was confirmed based on the failure analysis.The root cause is attributed to motion issues caused by warped communication cables (rolling loop).
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: DAVINCI SI
• Common Device Name: PATIENT SIDE CART, RECERTIFIED
• 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: 23280668
• Report Number: 2955842-2025-41518
• Device Sequence Number: 8956153
• Product Code: NAY
• UDI-Device Identifier: 00886874110775
• UDI-Public: (01)00886874110775
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K081137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2026

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: 380686-04
• Device Catalogue Number: N/A
• 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: 09/23/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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