None 470057Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,096 adverse event reports that list this exact device (DI 00886874116555), received between Sep 1, 2021 and Sep 30, 2026 — classified as 29 injuries, 1,067 malfunctions.

The most frequently reported specific device problem is “Image Orientation Incorrect” (689 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,096 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Image Orientation Incorrect

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954912 ↗
• MalfunctionSep 29, 2026Image Orientation Incorrect

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926766 ↗
• MalfunctionSep 25, 2026Image Orientation Incorrect

  It was reported that during a da Vinci-assisted surgical procedure, the 30-Degree Endoscope Plus image was being displayed as a double image and was inverted. The Technical Support Engineer (TSE) viewed the system logs and found related errors on the Endoscope, then advised the customer to replace the Endoscope. The customer confirmed that the replacement Endoscope resolved the issue. The procedure was completed with no reported injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50901511 ↗
• MalfunctionSep 24, 2026Crack

  It was reported that the customer experienced an issue with an Intuitive product. The customer reported event has no report of patient injury.ISI followed up with the initial reporter and obtained the following additional information: Central Processing Department identified a crack on the tip of the endoscope during inspection. The endoscope was removed from service and not used on a patient.

  Patient problems: Insufficient Information

  MAUDE report 50877577 ↗
• MalfunctionSep 24, 2026Crack

  It was reported that the customer experienced an issue with an Intuitive product. The customer reported event has no report of patient injury.ISI made multiple follow-up attempts to obtain additional information. However, no further details have been received as of the date of this report.

  Patient problems: Insufficient Information

  MAUDE report 50877545 ↗
• MalfunctionSep 22, 2026Image Orientation Incorrect

  It was reported that during a da Vinci-assisted high anterior resection surgical procedure, the 30-Degree Endoscope Plus base rotated stiffly. Sometimes the up-and-down inversion did not work. The procedure was completed with no reported injury.ISI followed up with the initial reporter and obtained the following additional information: Customer alleged that endoscope image was inverted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50852348 ↗
• MalfunctionSep 22, 2026Image Orientation Incorrect

  It was reported that during a da Vinci-assisted surgical procedure, an Endoscope Plus 30 degrees rotated with the view facing upward, the image was inverted. The procedure was completed with no reported injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50852013 ↗
• MalfunctionSep 18, 2026Image Orientation Incorrect

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50823683 ↗
• MalfunctionSep 17, 2026Image Orientation Incorrect

  It was reported that during a da Vinci-assisted surgical training procedure, the customer attempted to rotate the 30 degree Plus Endoscope upward or downward and noted that it would not remain stable in the selected position and moved unintentionally, making it difficult to maintain the desired field of view and perform the procedure properly. No known impact or patient consequence was reported.

  Patient problems: Insufficient Information

  MAUDE report 50808920 ↗
• MalfunctionSep 17, 2026Image Orientation Incorrect

  It was reported that during da Vinci-assisted surgical procedure, the customer observed the images were flipped upside down on the screen and Surgeon Side Console (SSC) when selecting 30 down. The customer replaced the Endoscopes with no resolution. The customer performed a system restart and the issue was resolved. The log review did not show any errors. The procedure was completed with no reported injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50806771 ↗
• MalfunctionSep 17, 2026Image Orientation Incorrect

  It was reported that during a da Vinci-assisted surgical procedure, user informed the Technical Support Engineer (TSE) that the orientation of the 30-degree endoscope appeared to differ from the Vision Side Cart (VSC) image by about 90 degrees, and reinstalling the sterile adapter and endoscope did not improve the issue. The user confirmed that the image was not the known condition where the 30-degree scope orientation was flipped and the image appeared upside down. The user continued the procedure without issue and planned to perform additional testing after the procedure. No known impact or patient consequence was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50806152 ↗
• MalfunctionSep 14, 2026Unintended System Motion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50763493 ↗
• MalfunctionSep 14, 2026Image Orientation Incorrect; Noise, Audible

  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 hos

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50757203 ↗
• InjurySep 14, 2026Detachment of Device or Device Component

  It was reported that during a da Vinci-assisted radical extraperitoneal prostatectomy with lymphadenectomy procedure, a portion of the Endoscope Plus 30-Degree instrument fractured. A fragment fell into the patient and was identified, accounted for, and retrieved during the same procedure. The patient was evaluated, and no retained foreign body remained. The procedure was completed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50754918 ↗
• MalfunctionSep 14, 2026Image Orientation Incorrect

  It was reported that during a da Vinci-assisted single internal mammary artery harvest surgical procedure, user informed the Technical Support Engineer (TSE) that the Endoscope image orientation appeared incorrect, and they power cycled the system to resolve the issue. The TSE reviewed the logs and did not find any related issues, then asked whether the scope flipping feature was used; the user stated it was used but it did not work. The TSE explained that the system retained memory related to the Endoscope and advised canceling the guided tool change in the future instead of power cycling to address the orientation issue. The user continued with the procedure using the same system configuration with no further issues. No known impact or patient consequence was reported.

  Patient problems: Insufficient Information

  MAUDE report 50751673 ↗
• MalfunctionSep 3, 2026Unintended System Motion

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50595528 ↗
• MalfunctionSep 2, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50575856 ↗
• MalfunctionSep 1, 2026Image Orientation Incorrect

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50547212 ↗
• MalfunctionAug 31, 2026Unintended System Motion

  It was reported that during da Vinci-assisted surgical procedure, site contacted Intuitive Technical Support Engineer (TSE) to report the 30-degree camera was orienting itself 90 degrees from horizontal and the Master Tool Manipulator (MTM) were following. Customer tried a new camera and the issue remained. A hard power cycle was done, and site reseated the Patient Side Cart (PSC) fiber cable. The camera then oriented properly. Surgeon took control of the instruments with TSE on the phone and reported the robot was working normally. Site was continuing with the case. The procedure was completed with no reported injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50525578 ↗
• MalfunctionAug 28, 2026Image Orientation Incorrect

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50509487 ↗
• MalfunctionAug 28, 2026Image Orientation Incorrect

  Patient problems: Insufficient Information

  MAUDE report 50509458 ↗
• MalfunctionAug 26, 2026Image Orientation Incorrect

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50457860 ↗
• MalfunctionAug 25, 2026Image Orientation Incorrect

  Patient problems: Insufficient Information

  MAUDE report 50442695 ↗
• MalfunctionAug 25, 2026Image Orientation Incorrect

  Patient problems: Insufficient Information

  MAUDE report 50442584 ↗
• MalfunctionAug 18, 2026Image Orientation Incorrect

  It was reported that during a da Vinci assisted Incisional Hernia eTEP surgical procedure, the customer informed the Technical Support Engineer (TSE) that they could not tell if the Endoscope orientation appeared correct. The customer replaced the Endoscope, but the issue did not change. The TSE then reviewed the logs and found no related errors, and the TSE walked the customer through removing the endoscope from Arm 3, orienting it to the desired position, pressing the arm 3 instrument clutch button twice to cancel guided tool change, and reinstalling the scope, after which the customer reported the problem did not persist. The procedure was completing as planned. No known impact or patient consequence was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50310763 ↗