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

Model Number	380620-39
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to starting pre anesthesia a da vinci-assisted surgical simple extraperitoneal prostatectomy procedure, the customer called to report a repeated recoverable error 32100 on universal surgical manipulator (usm) 1.The caller stated that he had recover the error twice, but it kept returning.An intuitive surgical, inc.(isi) technical support engineer (tse) reviewed error logs and could confirm error 32100 pointing to axes controller, motor (acm) on the usm.The tse guided him to restart the system including emergency power-off (epo) breakers, but issue remained.Tse informed customer that usm 1 would not be usable.The tse guided nurse to deactivate usm 1 and explained to her that the system can be used with three arms.Nurse spoke to the responsible surgeon, and the surgery will be cancelled.There was no 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 complaint.The fse was able to reproduce the issue and replaced the universal surgical manipulator (usm).The system was tested and verified as ready for use.As of the date of this report, the usm has not yet been received by isi for evaluation.

• Brand Name: daVinci X
• 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 ; +1(408)523-2100
• MDR Report Key: 50942413
• Report Number: 2955842-2026-40383
• Device Sequence Number: 10740003
• Product Code: NAY
• UDI-Device Identifier: 00886874115404
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K171294
• 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
• Report Date (Section B): 09/29/2026

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: 380620-39
• 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: 09/08/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2020
• 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: Male