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

Model Number	470057-08
Medical Device Problem Codes	Image Orientation Incorrect (1305); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer had an issue with the 30 degree endoscope scope movement, accompanied by noise from the mechanical parts.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the distributor field service engineer (fse) and obtained the following additional information: the endoscope moves slowly and produces an unusual noise during movement.In some cases, the endoscope would also rotate unexpectedly without user control.The customer confirmed that the endoscope moved freely with uncontrolled motion.There was no damage observed on the endoscope¿s adapter or base.Intuitive surgical, inc.(isi) followed up with another distributor field service engineer (fse) and obtained the following additional information: the fse clarified that as seen in the provided video, the scope had a mechanical noise, however, the endoscope worked without error with the surgeons.The endoscope worked normally with the surgeons until now.The fse heard that once there was a surgeon that felt a very brief uncontrolled movement.The fse did not have detailed information about this incident and it was not confirmed.The fse agreed with the hospital to exchange the scope and then the old scope would be sent back to intuitive for further analysis.There was no injury to the patient due to the issue.The procedure was completed with no delays.No fragment fell into the patient.
Additional Manufacturer Narrative
An investigation is in progress to determine the cause of this reported event.An rma was issued to evaluate the intuitive surgical, inc.(isi) device.Additional information is being gathered to determine the contribution of the device to the customer reported issue.An image and a video clip associated with this reported event were submitted for review.The attached image showed erosion of the delrin ring feature on the idler gear.This defect can result in failed engagement or unintuitive motion (delayed roll as seen in the video).

• 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: 50757203
• Report Number: 2955842-2026-38860
• Device Sequence Number: 13048677
• Product Code: GCJ
• UDI-Device Identifier: 00886874116555
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: K191736
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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: 470057-08
• 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: 08/24/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2022
• 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