None 372010Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00886874110447), received between Feb 23, 2022 and Jun 1, 2023 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (10 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2023Optical Distortion; Optical Distortion

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED HYSTERECTOMY SURGICAL PROCEDURE, THE 8.5MM 0-DEGREE ENDOSCOPE HAD BLURRY VISION IN ONE EYE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17038490 ↗
• MalfunctionJun 1, 2023Fogging; Fogging

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, IT WAS REPORTED THAT THE INSTRUMENT HAS FOGGING ISSUES. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17038487 ↗
• MalfunctionMay 27, 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 CUSTOMER NOTED THE ENDOSCOPE HAD A SPLIT PICTURE ON ONE OF THE LENS WHEN THE SURGEON LOOKED THROUGH THE SURGEON SIDE CONSOLE (SSC). THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015674 ↗
• MalfunctionMay 21, 2023Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE LENS ON DISTAL TIP OF THE ENDOSCOPE WAS MISSING. THE SITE REPORTED THAT THE "MIRRORS MIGHT NOT BE IN PROPER ORIENTATION" AND THAT THERE APPEARED TO BE SOME DAMAGE ON RIGHT THE SIDE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16971263 ↗
• MalfunctionMay 21, 2023Break; Moisture Damage; Detachment of Device or Device Component; Break; Moisture Damage; Detachment of Device or Device Component

  IT WAS REPORTED AFTER RECEIVING AN SI SLIDE, THE ENDOSCOPE INSTRUMENT WAS NON-FUNCTIONAL. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16971250 ↗
• MalfunctionMay 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE ENDOSCOPE HAD A POOR PICTURE QUALITY AND FOCUSING ISSUE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16971246 ↗
• MalfunctionMay 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE ENDOSCOPE HAD A BLURRY LENS AND A FOGGING ISSUE. THE PROCEDURE WAS CONTINUED AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16883635 ↗
• MalfunctionMay 6, 2023Break; Misfocusing; Detachment of Device or Device Component; Break; Misfocusing; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER OBSERVED THE ENDOSCOPE WAS NOT FOCUSING. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16883631 ↗
• MalfunctionMay 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER OBSERVED THE CAMERA HEAD HAD A FOGGY IMAGE. THE DEVICE WAS NOT USED ON THE PATIENT. A SPARE CAMERA HEAD WAS USED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16883627 ↗
• MalfunctionMay 6, 2023Poor Quality Image; Detachment of Device or Device Component; Poor Quality Image; Detachment of Device or Device Component

  IT WAS REPORTED PRIOR TO STARTING A DA VINCI-ASSISTED PROCEDURE THE ENDOSCOPE WAS FOUND TO BE BLURRY. THE USER SWAPPED TO BACK-UP SCOPE AND COMPLETED THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY NOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16883624 ↗
• MalfunctionMay 6, 2023Break; Poor Quality Image; Detachment of Device or Device Component; Break; Poor Quality Image; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED TOTAL BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE 8.5MM 0 DEGREE ENDOSCOPE HAD CLOUDY VISION IN BOTH EYES. 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 ENDOSCOPE WAS INSPECTED PRIOR TO USE. THE TECHNICIAN HAD NOTICED THE PROBLEM WITH THE SCOPE DURING CALIBRATION AND PRIOR TO PATIENT ARRIVING TO OPERATING ROOM, SCOPE WAS REMOVED FROM THE STERILE FIELD AND TAKEN FROM THE OPERATING ROOM PRIOR TO START OF PROCEDURE. NO FRAGMENT FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP ENDOSCOPE. THERE WAS NO PATIENT INJURY DUE TO THE ISSUE. NO IMAGES OR PATIENT DEMOGRAPHICS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16883297 ↗
• MalfunctionMay 6, 2023Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT THE ENDOSCOPE HAD DARK IMAGE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16883291 ↗
• MalfunctionMay 6, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PICTURE WAS VERY GRAINY AND ONE OF THE EYES WAS COMPLETELY BLURRY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16883286 ↗
• MalfunctionMar 9, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  THE ENDOSCOPE WAS RETURNED WITH NO REPORTED COMPLAINT. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) MADE SEVERAL ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER, BUT NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13702052 ↗
• MalfunctionMar 8, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED DURING CENTRAL PROCESSING AND CLEANING, THE ENDOSCOPE IMAGE WAS TOO DARK. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13691244 ↗
• MalfunctionFeb 28, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  THE ENDOSCOPE WAS RETURNED WITH NO REPORTED COMPLAINT. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13625820 ↗
• MalfunctionFeb 26, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING AN INTERNAL SERVICE ACTIVITY, AN ENDOSCOPE WAS RETURNED AS NON-DEFECTIVE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 13614870 ↗
• MalfunctionFeb 24, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  THE ENDOSCOPE WAS RETURNED WITH NO REPORTED COMPLAINT. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13595438 ↗
• MalfunctionFeb 23, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING INTERNAL SERVICE ACTIVITY, AN 8.5 MM ENDOSCOPE INSTRUMENT WAS RETURNED AS NON-DEFECTIVE FIELD REPLACEABLE UNITS (FRU) AND UPDATED TO A DEFECTIVE FRU DURING THE RETURN MATERIAL AUTHORIZATION PROCESS. THERE WAS NO REPORT OF PATIENT HARM, INJURY, OR ADVERSE OUTCOME. INTUITIVE SURGICAL, INC. (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 13583286 ↗