NA 26616ACARecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04048551426180), received between Nov 5, 2025 and Sep 29, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Poor Quality Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936914 ↗
• MalfunctionSep 23, 2026Unexpected Shutdown

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876093 ↗
• MalfunctionAug 20, 2026Poor Quality Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50354328 ↗
• MalfunctionApr 14, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE OPERATING ROOM TEAM INTERFACE (ORTI) SCREEN ON THE TOWER BEGAN FLICKERING AND BECAME FROZEN AFTER AN ENDOSCOPE ERROR MESSAGE WAS TRIGGERED. THE ISSUE WAS RESOLVED BY REPLACING THE ENDOSCOPE WITH A 30 DEGREE ENDOSCOPE. THERE WAS NO PATIENT INJURY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24874687 ↗
• MalfunctionApr 14, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE OPERATING ROOM TEAM INTERFACE (ORTI) SCREEN ON THE TOWER BEGAN FLICKERING AND BECAME FROZEN AFTER AN ENDOSCOPE ERROR MESSAGE WAS TRIGGERED. THE ISSUE WAS RESOLVED BY REPLACING THE ENDOSCOPE WITH A 30 DEGREE ENDOSCOPE. THERE WAS NO PATIENT INJURY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24873974 ↗
• MalfunctionMar 20, 2026Optical Distortion

  IT WAS REPORTED THAT, DURING A ROBOTIC LAPAROSCOPIC PROCEDURE, THE ENDOSCOPE'S LENS WAS INFILTRATED, RESULTING IN A BLURRED FIELD OF VISION ON THE IMAGE. THERE WAS NO PATIENT INJURY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24656030 ↗
• MalfunctionFeb 16, 2026Optical Distortion

  IT WAS REPORTED THAT, DURING A ROBOTIC LAPAROSCOPIC PROSTATECTOMY, THE ENDOSCOPE'S IMAGE WAS BLURRED AND UNFOCUSED. IT WAS EXCHANGED WITH A NEW ENDOSCOPE AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. THE EXCHANGE RESULTED IN A FIVE-MINUTE DELAY. THERE WAS NO PATIENT INJURY. CROSS REFERENCE MDR: 9610617-2026-00311.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24350023 ↗
• MalfunctionFeb 16, 2026Optical Distortion

  IT WAS REPORTED THAT, DURING A ROBOTIC LAPAROSCOPIC PROSTATECTOMY, THE ENDOSCOPE'S IMAGE WAS BLURRED AND UNFOCUSED. IT WAS EXCHANGED WITH A NEW ENDOSCOPE AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. THE EXCHANGE RESULTED IN A FIVE MINUTE DELAY. THERE WAS NO PATIENT INJURY. CROSS REFERENCE MDR: 9610617-2026-00310.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24350022 ↗
• MalfunctionDec 23, 2025Poor Quality Image; Insufficient Device Problem Information; Poor Quality Image; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE ENDOSCOPE IMAGE WAS BLURRY DURING PROCEDURE. IT APPEARED AS IF THE AUTOFOCUS OF THE CAMERA WAS NOT PERFORMING WELL. EXTERNAL MONITORS SHOWED THE SAME BLUR. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23884892 ↗
• MalfunctionNov 5, 2025Display or Visual Feedback Problem; Insufficient Device Problem Information; Display or Visual Feedback Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE ENDOSCOPE CAMERA DID NOT FUNCTION AND THERE WAS NO IMAGE. A NEW ENDOSCOPE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS A 5-MINUTE DELAY. THERE WAS NO PATIENT INJURY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23477135 ↗