NA TH121Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 04048551430569), received between Jul 11, 2025 and Sep 17, 2026 — classified as 2 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Poor Quality Image” (8 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026No Display/Image

  It was reported that "Camera head failed during a case-image went blank. Patient involved.". No negative impact in state of health reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50805450 ↗
• MalfunctionSep 16, 2026Poor Quality Image

  According to the information received, the device just received back from repair and same issue of Blurry image quality to send back to have it re-evaluated.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50789755 ↗
• MalfunctionSep 10, 2026Poor Quality Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722729 ↗
• MalfunctionSep 10, 2026Optical Distortion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722719 ↗
• MalfunctionSep 4, 2026Intermittent Continuity; No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50616732 ↗
• MalfunctionAug 18, 2026No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50310113 ↗
• MalfunctionAug 14, 2026Poor Quality Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50260358 ↗
• MalfunctionAug 11, 2026Excessive Heating

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50216343 ↗
• MalfunctionAug 7, 2026Erratic or Intermittent Display

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50177960 ↗
• MalfunctionAug 6, 2026Circuit Failure; No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50164326 ↗
• MalfunctionMar 3, 2026No Display/Image

  IT WAS REPORTED THAT THE "IMAGE DISAPPEARS DURING USE." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24496871 ↗
• MalfunctionJan 21, 2026Poor Quality Image

  ACCORDING TO THE INFORMATION RECEIVED, THE IMAGE IS BLURRY AND WILL NOT FOCUS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A BACK-UP DEVICE AND A 5 MIN DELAY. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24133921 ↗
• MalfunctionDec 19, 2025Image Display Error/Artifact; Image Display Error/Artifact

  IT WAS REPORTED: "OPERATING ROOM MINIMAL MOVEMENT WOULD CAUSE DISTORTION ON THE SCREEN INCONVENIENCE FOR DOCTOR DID NOT LIKE IMAGE. NO PATIENT WAS INJURED OR HARMED DID SWITCH TO ANOTHER KARL STORZ CAMERA WITH BETTER QUALITY". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23853579 ↗
• MalfunctionDec 19, 2025Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT THEATRE 5 NCEPOD LIST OUT OF HOURS AT 1930 WHILE COMPLETING SURGERY FOR +/- LAPAROSCOPY THE IMAGE BECAME FOGGY ON THE SCREEN. THE THEATRE STAFF SWAPPED THE SCOPE FOR ANOTHER ONE, BUT DID NOT REPLACE THE LIGHT LEAD THE IMAGE IMPROVED, BUT ONLY FOR A SHORT WHILE. THEY THEN REPLACED THE CAMERA HEAD FOR ANOTHER ONE AND THE PROBLEM WAS RESOLVED. IT IS REPORTED THAT THE CASE WAS PROLONGED FOR APPROXIMATELY 15 MINUTES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23851365 ↗
• MalfunctionDec 12, 2025Poor Quality Image; Poor Quality Image

  IT WAS REPORTED A MISTY AND BLURRED IMAGE ON THE CAMERA STACK SCREEN. THE SCOPE HAD BEEN CHANGED BUT DID NOT SOLVE THE PROBLEM. THE CAMERA HEAD LENS HAD BEEN CLEANED BUT THIS ALSO DID NOT RESOLVE THE ISSUE. THEN THE CAMERA HEAD HAD BEEN CHANGED FOR ANOTHER SIMILAR UNIT, THIS TOOK A FEW MINUTES TO ACHIEVE. THIS RESOLVED THE PROBLEM AND THE SURGERY WAS ABLE TO PROCEED AFTER APPROXIMATELY A 10 MINUTE DELAY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23791641 ↗
• MalfunctionDec 8, 2025Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT THE DEVICE HAS A FOGGY IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23746888 ↗
• MalfunctionNov 26, 2025Optical Distortion; Optical Distortion

  IT WAS REPORTED: "THE IMAGE WAS OFF CENTER; THE CONNECTION WAS POOR TO THE TOWER BY LOSING SIGNAL AND THE IMAGE WAS BLURRY". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23660632 ↗
• MalfunctionNov 21, 2025Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event

  IT WAS REPORTED THAT POOR IMAGE QUALITY IS OBSERVED DURING SURGERY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622516 ↗
• InjuryJul 18, 2025Image Display Error/Artifact; Image Display Error/Artifact

  IT WAS REPORTED THAT THE CAMERA HAD A HAZY IMAGE AND HALO EFFECT AROUND THE IMAGE. AFTER SWITCHING CAMERAS THERE WAS IMPROVEMENT BUT DUE TO BLEEDING AND SOME CONTINUED VISUALIZATION ISSUES THE CASE HAD TO BE CANCELLED. CROSS REFERENCE MDR: 2027009-2025-01229.

  Patient problems: Insufficient Information

  MAUDE report 22546403 ↗
• InjuryJul 18, 2025Image Display Error/Artifact; Image Display Error/Artifact

  IT WAS REPORTED THAT THE CAMERA HAD A HAZY IMAGE AND HALO EFFECT AROUND THE IMAGE. AFTER SWITCHING CAMERAS THERE WAS IMPROVEMENT BUT DUE TO BLEEDING AND SOME CONTINUED VISUALIZATION ISSUES THE CASE HAD TO BE CANCELLED. CROSS REFERENCE MDR: 2027009-2025-01230.

  Patient problems: Insufficient Information

  MAUDE report 22546402 ↗
• MalfunctionJul 18, 2025Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT FLICKERING AND CAMERA GETTING DISCONNECTED DURING PROCEDURE A FEW TIMES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22542667 ↗
• MalfunctionJul 11, 2025Erratic or Intermittent Display; Adverse Event Without Identified Device or Use Problem; Erratic or Intermittent Display; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT "UNIT BLANKS OUT AND IMAGE FLICKERING OCCURRED". IT WAS CONFIRMED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT, USER OR THIRD PARTY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDRS: 9610617-2025-01210, 9610617-2025-01212.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22482863 ↗