NA 26616BCARecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04048551426166), received between Nov 21, 2025 and Sep 29, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Poor Quality Image” (4 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 8 most recent of 8 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 50937643 ↗
• MalfunctionMay 29, 2026Display or Visual Feedback Problem

  THE FOLLOWING WAS REPORTED: "IT WAS REPORTED THAT, DURING A ROBOTIC LAPAROSCOPIC PROCEDURE, THE SYSTEM DROPPED AN ENDOSCOPE IMAGE FROZEN ERROR AND THE IMAGE ON THE OPERATING ROOM TEAM INTERFACE (ORTI) WENT BLACK. THE ERROR AND THE IMAGE RECOVERED BY ITSELF AND THE SURGERY WAS PROCEEDED. THERE WAS NO PATIENT INVOLVEMENT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25336955 ↗
• MalfunctionApr 8, 2026Poor Quality Image

  IT WAS REPORTED THAT A WHITISH HAZE WAS OBSERVED ON THE LEFT LENS. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24818980 ↗
• MalfunctionMar 23, 2026Poor Quality Image; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC PROSTATECTOMY, AFTER ABOUT 3 HOURS OF PROCEDURE TIME, THE VISUALIZATION OF THE PATIENT CAVITY TOOK ON A GREEN/YELLOW HUE. THE CAMERA WAS CLEANED AND THE WHITE REBALANCED. THE ISSUE RETURNED AFTER ABOUT 10 MINUTES AND THE CAMERA RETURNED TO THE DARK, GREEN/YELLOW STATE. THE CLEANING PROCESS WAS REPEATED INTERMITTENTLY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24670876 ↗
• MalfunctionMar 11, 2026Poor Quality Image; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE TIPCAM PROVIDED POOR IMAGE QUALITY DURING THE PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24573389 ↗
• MalfunctionMar 11, 2026Display or Visual Feedback Problem; Device Damaged Prior to Use

  THE FOLLOWING WAS REPORTED: IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THE FOLLOWING ERROR APPEARED ON THE SCREEN DANGER: FROZEN ENDOSCOPE IMAGE. CHECK THE ENDOSCOPIC SYSTEM. IF THE ISSUE PERSISTS, RETRIEVE THE INSTRUMENTS AND STOP THE SYSTEM USE. THE STORZ VIDEO FEED INITIALLY LAGGED AND FROZE, THEN TURNED COMPLETELY GREEN. THE TEAM RESTARTED THE STORZ SYSTEM, AND THE SURGERY WAS ABLE TO CONTINUE. THERE WAS A 2-3 MINUTE DELAY DUE TO THIS ISSUE. THERE WAS NO PATIENT INJURY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24573124 ↗
• MalfunctionFeb 10, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE TEAM LOST LIGHT IN TWO INSTANCES. THE IMAGE APPEARED AS IF IN SHADOW AND COULD NOT BE CORRECTED BY MOVING THE CAMERA (IN CASE IT WAS REAL SHADOW DUE TO ANY TISSUE. THE LIGHT WAS ONLY RESTORED BY WITHDRAWING AND REINTRODUCING THE ENDOSCOPE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24306312 ↗
• MalfunctionNov 21, 2025Circuit Failure; No Display/Image; Circuit Failure; No Display/Image

  ACCORDING TO THE INFORMATION RECEIVED, SURGICAL IMAGE WAS LOST AND A BLUE SCREEN WAS SHOWN. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23615566 ↗