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	05/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported event.Based on the field evaluation, this reported event was not confirmed.Fse confirmed with customer that system was rebooted.Endoscope flipping issue was resolved after the reboot.The system was tested and verified as ready for use.The complaint was not confirmed based on the field evaluation.
Event or Problem Description
It was reported that during a da vinci assisted paraesophageal hiatal hernia surgical procedure, intuitive surgical, inc.(isi) clinical territory associate (cta) informed technical support engineer (tse) that the endoscope image was flipping.The tse explained potential causes for the endoscope flipping when reinstalled on the arm after cleaning.Tse reviewed the system logs and observed that no instruments were installed at that time.The tse advised the cta to perform a hard power cycle and to monitor the issue for the next procedure.Tse also provided guidance on an in-procedure workaround by cancelling the guide tool change (gtc) to restore proper image orientation.The procedure was completing as planned with no reported injury.

• 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: 25364492
• Report Number: 2955842-2026-26568
• Device Sequence Number: 10650593
• Product Code: GCJ
• UDI-Device Identifier: 00886874120286
• UDI-Public: (01)00886874120286
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/02/2026

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2025
• 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