MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC da Vinci SP; PATIENT SIDE CART

Model Number	380601-51
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during training/demo that the boom had not been retracting or extending properly.The caller stated that the system had not been going into sterile stow and also stated that the entry guide manipulator (egm) had not been rotating 360 degrees.There was no report of patient involvement.
Additional Manufacturer Narrative
An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported event.Fse was onsite to troubleshoot an issue with the boom on the single-port (sp) system and identified error 23041.After startup, fse attempted to move the boom horizontally using the manual joysticks; however, the boom would not move despite multiple attempts.Fse then used the entry guide manipulator (egm) and port clutch to manually move the boom horizontally and was able to do so, although noticeable resistance was present.Afterward, fse used the handlebar joystick and was able to move the boom horizontally in and out without issue.Fse removed the boom covers and inspected the assembly for any broken or loose components but found none.Fse then continued testing by moving the boom horizontally in and out with the joystick to determine whether the rail guides were loose; no looseness was observed.After reinstalling the covers, fse continued testing and was able to reproduce the issue multiple times, with the boom becoming stuck approximately halfway to its maximum extension.While manually moving the boom horizontally using the egm and port clutch, fse heard a grinding noise.Based on the troubleshooting findings, a possible boom motor assembly and arm controller (platform) board replacement were recommended, as well as inspecting the rail guides for looseness.Fse completed a test drive of the system.System was tested and verified ready for use.The complaint was confirmed based on the field evaluation.The probable root cause could not be determined based on the field servicing notes.Blank mdr fields: 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.Information for the blank fields in section e1 is not available.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.

• 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 ; +1(408)523-2100
• MDR Report Key: 50203249
• Report Number: 2955842-2026-35197
• Device Sequence Number: 12133129
• Product Code: NAY
• UDI-Device Identifier: 00886874114605
• UDI-Public: (01)00886874114605
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

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: 380601-51
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2024
• 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