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	05/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted colostomy closure surgical procedure, the customer encountered an issue with the camera horizon.The customer reported that the horizon was correct on the vision side cart (vsc) and matched the physical orientation of the 30-degree endoscope, but the horizon at the surgeon side console (ssc) was incorrect.Intuitive surgical, inc.(isi) technical support engineer (tse) recommended reseating the endoscope and rebooting the system if the issue persisted.The procedure was completing as planned with no reported injury.Isi followed up with the csr and obtained the following additional information: the endoscope moved freely with uncontrolled motion.The event did not involve a reversed control on the system arms, only the endoscope positioning was off.No damage was observed on the endoscope¿s adapter/base.The endoscope was unplugged and plugged back in, and a system restart was performed; however, the issue persisted.The case was completed with the same endoscope.Customer reseated and cancelled guided tool change to fully reset the position, but the error still occurred.
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 tested the system using an alternate endoscope and observed no difference in the horizon displayed between the surgeon side console (ssc) and the vision side cart (vsc) during endoscope movement and operation.The system functioned and displayed properly when used with the alternate endoscope.The system was tested and verified as ready for use.Isi did not receive the da vinci product with an alleged issue to perform failure analysis.Although the complaint was not confirmed by failure analysis since the product was not returned, the information gathered during the field evaluation indicates that the device may have contributed to the customer reported issue.

• 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: 25333189
• Report Number: 2955842-2026-26252
• Device Sequence Number: 13231795
• Product Code: GCJ
• UDI-Device Identifier: 00886874120286
• UDI-Public: (01)00886874120286
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/29/2026

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: 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: 05/06/2026
• Initial Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/17/2025
• 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