MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; ENDOSCOPE

Model Number	470067-18
Medical Device Problem Code	Image Orientation Incorrect (1305)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.The reported event was addressed with phone support.Field service engineering (fse) confirmed with robotics coordinator that after performing a system restart all issues were resolved.No additional issues or errors reported.No site visit was conducted.The system was working properly and no additional action was required as the issue was resolved.The probable root cause could not be definitively established as the phone details did not specify a potential causality related/attributive to the reported issue.Field service engineering (fse) confirmed with robotics coordinator that after performing a system restart all issues were resolved.
Event or Problem Description
It was reported that the operating room manager stated that, prior to the start of the case, the image appeared flipped.The surgeon then restarted the system, after which the image returned to normal and no further troubleshooting was required.The customer reported event has no report of patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter on and obtained the following additional information: no specific scope or instrument identified, it happened on multiple cases.There are no photos for review.

• Brand Name: NONE
• Common Device Name: ENDOSCOPE
• 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: 24982677
• Report Number: 2955842-2026-21577
• Device Sequence Number: 18552442
• Product Code: GCJ
• UDI-Device Identifier: 00886874120286
• UDI-Public: (01)00886874120286
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/24/2026

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: 470067-18
• Device Catalogue Number: 470067
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/05/2026
• 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 Age: 34 YR
• Patient Sex: Male
• Patient Weight: 103 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White