MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI SP; PATIENT SIDE CART

Model Number	380601-40
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported event.Fse replaced the patient side manipulator (psm) due to damaged cabling.The system was tested and verified as ready for use.The complaint was confirmed based on field evaluation.Isi has received the psm for evaluation, but evaluation has not been completed as of the date of this report.A follow-up mdr will be submitted, if additional information is obtained.
Event or Problem Description
It was reported that after a da vinci-assisted nephrectomy surgical procedure, user informed the technical support engineer (tse) that the universal surgical manipulator (usm3) was damaged during removal of the sterile adapter.Tse requested photos of the damage from the user.After the photos were received and reviewed, tse determined that usm3 would not be functional due to the observed damage.The procedure was completed as planned using the original system configuration.No known impact or patient consequence was reported.

• Brand Name: DA VINCI SP
• Common Device Name: PATIENT SIDE CART
• 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: 25022504
• Report Number: 2955842-2026-23095
• Device Sequence Number: 9323539
• Product Code: NAY
• UDI-Device Identifier: 00886874114605
• UDI-Public: (01)00886874114605
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2026

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: 380601-40
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/07/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2020
• 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