MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI; PATIENT SIDE CART, 4-ARM

Model Number	380614-16
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported event.The fse went on-site and replaced the patient side manipulator (psm) 1.The system was verified and ready for use.Intuitive surgical, inc.(isi) has not received the da vinci product with an alleged issue to perform failure analysis.A follow-up mdr will be submitted if the product is returned and evaluated and/or if additional information is received.
Event or Problem Description
It was reported that during a da vinci-assisted simple transabdominal prostatectomy surgical procedure, patient side manipulator (psm) 1 could not grasp tissue well.Technical support engineer (tse) recommended reseating the sterile adapter (sa).The caller stated that it had not worked.The procedure was completed.The caller hadn't noticed errors or any message info appeared.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the customer noted system functionality was checked upon powering on the system and it powered on without any errors.Site re-installed the sterile adapter and instrument twice to continue the procedure and continued to use the arm#1 and arm#2 to complete the procedure.There was no injury reported to the patient.The surgeon did not disable arm#1.The procedure completed robotically with 3 arms and did not need to use the arm#3.
Additional Manufacturer Narrative
Intuitive surgical inc.(isi) received the patient side manipulator 2 for failure analysis investigation.The unit was analyzed and log was indicating that the axis psm #1 couldn't grasp tissue well during procedure.Upon visual inspection, no issues were found related to the reported event.Installed the psm onto a golden system where no faults occurred in normal mode and the unit functioned as expected.Completed functional tests where passed all tests.The complaint was confirmed but not replicated by failure analysis.While the definitive root cause could not be established as failure analysis could not replicate the customer-reported issue, a possible cause is attributed to mechanical defect of the 4 wrist pulley assemblies in the psm.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: DAVINCI SI
• Common Device Name: PATIENT SIDE CART, 4-ARM
• 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: 24783899
• Report Number: 2955842-2026-20389
• Device Sequence Number: 6134740
• Product Code: NAY
• UDI-Device Identifier: 00886874110690
• UDI-Public: (01)00886874110690
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2026

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: 380614-16
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/20/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2018
• 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