MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC None; ENDOSCOPE PLUS

Model Number	470057-12
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during da vinci-assisted surgical procedure, the customer observed issues with universal surgical manipulator (usm) 3 during the case.The customer informed the technical support engineer (tse) there were no yellow lights or error messages on arm or system, but they were unable to advance camera on usm 3.The customer attempted to fix the issue for a bit and eventually were able to advance the endoscope into the patient and continued using arm 3.The customer informed the endoscope moved by itself during the case while it was on usm 3.No error messages were observed.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 image was not inverted.But the endoscope moved freely with uncontrolled motion.There was some resistance when advancing the endoscope into the patient.The case was completed with the same endoscope.The customer informed the endoscope went to back in circulation without issue.
Additional Manufacturer Narrative
The reported event was addressed with phone support.The technical support engineer (tse) guided the customer through a hard power cycle, after which the system started normally.Log review did not identify any errors related to arm 3, although repeated error 22028 events were noted on universal surgical manipulator (usm) 2 from the previous week.The field service engineer (fse) confirmed with robotics coordinator that there have been no further issues with the arm.No site visit was conducted.The system was working properly and no additional action was required as the issue was resolved.

• Brand Name: None
• Common Device Name: ENDOSCOPE PLUS
• 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: 50595528
• Report Number: 2955842-2026-37746
• Device Sequence Number: 21206505
• Product Code: GCJ
• UDI-Device Identifier: 00886874116555
• UDI-Public: (01)00886874116555
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K191736
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/03/2026

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: 470057-12
• Device Catalogue Number: 470057
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2024
• 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 Age: 54 YR
• Patient Sex: Male
• Patient Weight: 206 LB