None 372011Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00886874110454), received between May 6, 2023 and May 27, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE ENDOSCOPE HAD CLOUDY IMAGE ISSUES PRIOR TO STARTING THE DA VINCI-ASSISTED PROCEDURE. A SPARE SCOPE WAS USED FOR THE PROCEDURE. THE DEFECTIVE SCOPE WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015673 ↗
• MalfunctionMay 21, 2023Break; Break

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED BILATERAL INGUINAL HERNIA PROCEDURE, THE SCOPE WOULD NOT PASS THE BALANCE TEST. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORT OF PATIENT HARM, ADVERSE OUTCOME OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16971289 ↗
• MalfunctionMay 21, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE REPORTER COMPLAINED THAT THE GLASS OF THE ENDOSCOPE WAS NOT AT THE TIP AND A SPARE ENDOSCOPE WAS USED. THE LENS WAS ALSO CLOUDY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16971207 ↗
• MalfunctionMay 21, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO STARTING THE DA VINCI-ASSISTED PROCEDURE THE CUSTOMER HAD CALIBRATION ISSUES ON THE SCOPE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16971205 ↗
• MalfunctionMay 6, 2023Break; Fogging; Detachment of Device or Device Component; Break; Fogging; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 30 DEGREE ENDOSCOPE WHITE BALANCE WAS FOGGY AND WAS FOUND WITH SMUDGING AND MOISTURE UNDER THE SCOPE LENS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16883630 ↗
• MalfunctionMay 6, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO A DA VINCI-ASSISTED SURGICAL PROCEDURE, A GLASS LENS OF AN ENDOSCOPE WAS MISSING. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16883618 ↗
• MalfunctionMay 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING THAT, THE ENDOSCOPE HAD A FOGGING ISSUE AND WAS MISSING LENS. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED-UP AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ABOUT THE COMPLAINT: THE ISSUE WAS DISCOVERED DURING CENTRAL PROCESSING, BUT THE ENDOSCOPE WAS NOT DAMAGED DURING CENTRAL PROCESSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16883293 ↗
• MalfunctionMay 6, 2023Failure to Calibrate; Failure to Calibrate

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 30-DEGREE ENDOSCOPE WOULD NOT CALIBRATE. A SPARE ENDOSCOPE WAS USED TO RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETED AS PLANNED. THE ENDOSCOPE WAS NOT USED ON A PATIENT AT THE TIME THE ISSUE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16883289 ↗
• MalfunctionMay 6, 2023Optical Distortion; Optical Distortion

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE ENDOSCOPE HAD BLURRY IMAGE ISSUES AND HAD A MISSING LENS. THE PROCEDURE WAS COMPLETED WITH A SPARE ENDOSCOPE WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16883284 ↗