MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC daVinci 5; Patient Side Cart

Model Number	380747-46
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted cholecystectomy surgical procedure, intuitive surgical, inc.(isi) clinical sales representative (csr) informed technical support engineer (tse) that when the surgeon was using head in menu to change from 30 up to 30 down, the horizon was inverted.The surgeon had to manually move the orientation to resolve the issue.The endoscope was installed on universal surgical manipulator (usm) 2.The customer continued to use usm 2 for the procedure.The procedure was completing as planned with no reported injury.On the following day, the csr called in to provide more information about the issue.The tse was informed that the issue had not recurred during the subsequent case.The tse walked the csr through checking the presence pins on the universal surgical manipulator (usm) and the disc integrity, with the csr verifying that all felt solid and that no oddities were found.The tse then had the csr compare the carriage integrity of the usm to another usm, and the csr confirmed that no irregularities were found.The tse advised the csr that if the issue were to occur again on the usm, port hopping could be utilized as an option.
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 replaced universal surgical manipulator (usm) 2 because multiple endoscopes had the same issue of flipping image on the same usm 2.The system was tested and verified as ready for use.A return material authorization (rma) was issued to the customer requesting to have the intuitive surgical, inc.(isi) device returned.Additional information is being gathered to determine the contribution of the device to the customer reported issue.

• Brand Name: daVinci 5
• 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: 50852640
• Report Number: 2955842-2026-39600
• Device Sequence Number: 21206794
• Product Code: NAY
• UDI-Device Identifier: 00886874119716
• UDI-Public: (01)00886874119716
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K232610
• 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): 09/22/2026

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: 380747-46
• 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: 09/15/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2026
• 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