NA 95-3908Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04250480109076), received between Oct 7, 2024 and Apr 23, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Thermal Decomposition of Device” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026No Apparent Adverse Event

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24961846 ↗
• MalfunctionMar 19, 2026Thermal Decomposition of Device

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED VISIBLE BURN MARKS ON THE NEAR INFRARED (NIR) HANDHELD CAMERA HEAD. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24646131 ↗
• MalfunctionMar 18, 2026Thermal Decomposition of Device

  IT WAS REPORTED THAT THE CUSTOMER OBSERVED BURN MARKS ON THE CORD OF THE NEAR INFRARED (NIR) CAMERA CABLE. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24635446 ↗
• MalfunctionMar 18, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SCHOELLY HANDHELD CAMERA WAS NOT CONNECTING, AND COLOR BARS WERE DISPLAYED ON THE MONITOR OF THE VISION SIDE CART (VSC). THE CUSTOMER STATED THEY HAVE HAD MULTIPLE CONNECTION ISSUES WITH THE SCHOELLY HANDHELD CAMERA ASSOCIATED WITH THIS EVENT. IT WAS STATED THEY WOULD CLEAN THE CAMERA CONNECTOR WITH AN ALCOHOL WIPE AND "SOMETIMES THAT WOULD FIX THE CONNECTION ISSUE." HOWEVER, ONCE SENT THROUGH THE STERILIZATION PROCESS IT WOULD NO LONGER CONNECT. A BACKUP SCHOELLY HANDHELD CAMERA WAS REQUESTED AND INSTALLED WHICH CAUSED A 5-MINUTE SURGICAL DELAY. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO REPORTED PATIENT INJURY, AND THE PATIENT WAS DISCHARGED HOME THE SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24629829 ↗
• MalfunctionMar 5, 2026Overheating of Device

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE DRAPE HAD A VERY SMALL HOLE SWITCHING FROM LAPAROSCOPIC TO ROBOT. THE LIGHT CORD WAS LEFT ON DRAPE WHILE OFF. THE DOCTOR LEFT IT ON THE PATIENT FOR EXTENDED PERIOD OF TIME. BOTH TIMES, THE LIGHT CORD WAS DETACHED FROM SCOPE AND LEFT ON PATIENT. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE LIGHT CORD BURNED A HOLE IN THE DRAPE. THERE WAS NO SMOKE, BUT THE LIGHT CORD MELTED A HOLE THROUGH THE DRAPE. THE HOLE WAS FOUND AT THE END OF THE PROCEDURE. THE ISSUE DID NOT AFFECT THE CASE. THERE WAS NO HARM TO THE PATIENT. THERE WAS NO HARM TO THE STAFF. THE CUSTOMER IS NOT PLANNING TO RETURN THE LIGHT CORD. THE CUSTOMER REQUESTED A RETRAINING ON USING THE LIGHT CORD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24523819 ↗
• MalfunctionMar 5, 2026Overheating of Device

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE DRAPE HAD A VERY SMALL HOLE SWITCHING FROM LAPAROSCOPIC TO ROBOT. THE LIGHT CORD WAS LEFT ON DRAPE WHILE OFF. THE DOCTOR LEFT IT ON THE PATIENT FOR EXTENDED PERIOD OF TIME. BOTH TIMES, THE LIGHT CORD WAS DETACHED FROM SCOPE AND LEFT ON PATIENT. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE LIGHT CORD BURNED A HOLE IN THE DRAPE. THERE WAS NO SMOKE, BUT THE LIGHT CORD MELTED A HOLE THROUGH THE DRAPE. THE HOLE WAS FOUND AT THE END OF THE PROCEDURE. THE ISSUE DID NOT AFFECT THE CASE. THERE WAS NO HARM TO THE PATIENT. THERE WAS NO HARM TO THE STAFF. THE CUSTOMER IS NOT PLANNING TO RETURN THE LIGHT CORD. THE CUSTOMER REQUESTED A RETRAINING ON USING THE LIGHT CORD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24523713 ↗
• InjuryFeb 20, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED REVISION BAND TO DUODENAL SWITCH SURGICAL PROCEDURE, THE PATIENT SUSTAINED A BURN FROM THE SCHOELLY CAMERA. THE CAMERA WAS TURNED OFF AFTER USE AND LEFT PLUGGED IN WHEN STORED IN THE STERILE DRAPE SIDE POCKET. THE CAMERA TIP WAS STILL WARM AND THE HEAT MELTED THE STERILE DRAPE AND LEFT A BURN ON THE PATIENT THE SIZE OF A QUARTER. OINTMENT WAS ORDERED FOR THE BURN. THERE WAS NO ADDITIONAL TISSUE RESECTION OR FURTHER INTERVENTION REQUIRED. THERE WERE NO DA VINCI RELATED COMPLICATIONS OR ISSUES INTRAOPERATIVELY. THE PATIENT WAS REPORTED TO BE DOING WELL POSTOPERATIVELY.

  Patient problems: Burn(s)

  MAUDE report 24407888 ↗
• MalfunctionFeb 4, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE NIR HANDHELD CAMERA HAD A UNKNOWN ISSUE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 24262864 ↗
• MalfunctionNov 19, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE NIR HANDHELD CAMERA HAD A PIECE BREAK OFF AT THE DISTAL END. CENTRAL PROCESSING REPORTED THE ISSUE. THE CUSTOMER IS UNSURE WHEN THE ISSUE OCCURRED. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23599678 ↗
• MalfunctionNov 21, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE HANDHELD CAMERA HAD BURN MARKS ON THE OUTSIDE. THERE WAS NO REPORTED PATIENT IMPACT OR HARM. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THEY NOTICED THE BURN MARKS BEFORE PROCESSING IT. THERE WAS NO HARM TO THE PATIENT OR SURGICAL STAFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20754298 ↗
• MalfunctionOct 7, 2024Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY SURGICAL PROCEDURE, THE CUSTOMER SMELLED A BURNING SMELL AND NOTICED THAT THE HANDHELD CAMERA WAS IN A SEPARATE DRAPE AND HAD BURNT THROUGH THE DRAPE. THEY STATED THAT THE CAMERA AND THE LIGHTGUIDE WERE DETACHED BUT THE LIGHT GUIDE HAD A RED LIGHT COMING OUT OF IT. THE LIGHT WAS RED POSSIBLE BEING SHINED THROUGH A BLUE DRAPE. THE CUSTOMER STATED THEY TURNED OFF THE LIGHT SOURCE WHEN THEY GOT DONE USING IT PRIOR TO PUTTING IT IN A DRAPE. THE LIGHT SOURCE WAS ATTACHED TO THE SCOPE PORTION OF THE HANDHELD THE ENTIRE TIME. IT WAS STATED EITHER THEY BUMPED THE CAMERA BUTTON FOR TURNING ON THE LIGHT SOURCE OR THEY FORGOT TO TURN THE LIGHT SOURCE OFF WHEN THEY PUT IT IN THE DRAPE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE LIGHT GUIDE WAS PLACED INTO A POCKET ON THE DRAPE WHEN THE INCIDENT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20390072 ↗