n.a. TL400Recalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 04048551425695), received between Aug 9, 2022 and Sep 30, 2026 — classified as 18 injuries, 64 malfunctions.

The most frequently reported specific device problem is “Energy Output Problem” (14 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 25 most recent of 82 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Output Problem

  The following was reported: "The customer reported that during surgical use, the light source automatically entered standby mode (bulb turned off) without any user operation." No negative impact in state of health reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942573 ↗
• MalfunctionSep 16, 2026Output below Specifications

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794727 ↗
• MalfunctionAug 27, 2026No Display/Image

  The following was reported: "went black and would not power back on" No negative impact in state of health reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50484057 ↗
• MalfunctionAug 12, 2026Intermittent Loss of Power

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50223677 ↗
• MalfunctionApr 22, 2026Energy Output Problem

  IT WAS REPORTED THAT THERE IS A "LIGHT DEFECTIVE". NO NEGATIVE IMPACT ON STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24959821 ↗
• MalfunctionApr 7, 2026Power Problem

  IT WAS REPORTED THAT IT WAS REPORTED THAT, DURING A ROBOTIC LAPAROSCOPIC SIGMOIDECTOMY PROCEDURE, PRIOR TO PERFORMING THE ANASTOMOSIS, NO STRUCTURES APPEARED FLUORESCENT GREEN AFTER ACTIVATION OF THE INDOCYANINE GREEN (ICG) MODE. AFTER ADMINISTERING INDOCYANINE GREEN (ICG) TO THE PATIENT AT THE CORRECT DILUTION AND VOLUME, THE SURGEON ADJUSTED THE SETTINGS TO ACTIVATE THE FLUORESCENCE MODE. THE ENDOSCOPE RESPONDED WHEN THIS OPTION WAS SELECTED; HOWEVER, NO STRUCTURES APPEARED FLUORESCENT (GREEN). AN ADDITIONAL SMALL DOSE OF ICG WAS ADMINISTERED, BUT VISUALIZATION WAS STILL NOT ACHIEVED. THE ENDOSCOPE WAS THEN RESTARTED, BUT THIS DID NOT RESOLVE THE ISSUE. THE SURGERY WAS COMPLETED WITHOUT THE USE OF ICG. THERE WAS NO PATIENT INJURY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE 9610617-2026-770.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24800999 ↗
• MalfunctionApr 1, 2026Output Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC HYSTERECTOMY, AN ERROR MESSAGE SHOWED ON THE TOWER FOR AN ENDOSCOPE FAILURE. THE ERROR COULD NOT BE DISCARDED. THE STORZ MODULE WAS REBOOTED, WHICH RESOLVED THE ISSUE. THE ISSUE DID NOT RECUR AND THERE WAS NO PATIENT INJURY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR 9610617-2026-00724.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24759834 ↗
• MalfunctionMar 19, 2026Complete Loss of Power

  THE FOLLOWING WAS REPORTED THAT THE LIGHT SOURCE BLEW OUT IN THE MIDDLE OF THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 24644464 ↗
• MalfunctionMar 9, 2026Image Display Error/Artifact

  IT WAS REPORTED THAT PRIOR TO PYELOPLASTY PROCEDURE, THERE WAS A FROZEN IMAGE ERROR WHICH WAS NOT DISMISSIBLE. THE SURGICAL SITE WAS NOT VISIBLE WHEN THE IMAGE FROZEN OCCURRED. THE ISSUE DID NOT RESOLVE EVEN AFTER TURNING OFF AND ON THE TL400. THE TC304 AND TL400 WAS TURNED OFF AND BACK ON TO RESOLVE THE ISSUE. THE PATIENT WAS NOT PRESENT IN THE OPERATING ROOM WHEN THE EVENT OCCURRED. THE PATIENT WAS IN THE ANAESTHETIC ROOM. THERE WAS A 5 MINUTE DELAY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR: 9610617-2026-00435.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24552288 ↗
• MalfunctionMar 6, 2026Failure to Power Up

  IT WAS REPORTED THAT "THE LIGHT SOURCE DOES NOT TURN ON AND THERE ARE BLOWN FUSES". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24539671 ↗
• MalfunctionMar 5, 2026Energy Output Problem

  IT WAS REPORTED THAT "LIGHT SOURCE CAN NO LONGER BE OPERATED". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24515630 ↗
• MalfunctionFeb 23, 2026Complete Loss of Power

  THE FOLLOWING WAS REPORTED: "FUSE BLOW OUT. SUSPECT THE POWER SUPPLY BOARD DEFECTIVE." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24412444 ↗
• 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 24306322 ↗
• InjuryFeb 10, 2026Poor Quality Image

  IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC VENTRAL HERNIA REPAIR PROCEDURE, THE RESOLUTION AND COLOR OF THE VISUALIZATION WAS APPEARING RED. THE SURGEON CONVERTED TO LAPAROSCOPY BECAUSE THE IMAGE TURNED RED WHEN OPERATING NEAR THE ABDOMINAL WALL. ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT SUFFERED A NON-SERIOUS INJURY.

  Patient problems: Insufficient Information

  MAUDE report 24302621 ↗
• InjuryFeb 10, 2026Poor Quality Image

  IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC VENTRAL HERNIA REPAIR PROCEDURE, THE RESOLUTION AND COLOR OF THE VISUALIZATION WAS APPEARING RED. THE SURGEON CONVERTED TO LAPAROSCOPY BECAUSE THE IMAGE TURNED RED WHEN OPERATING NEAR THE ABDOMINAL WALL. ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT SUFFERED A NON-SERIOUS INJURY.

  Patient problems: Insufficient Information

  MAUDE report 24302605 ↗
• MalfunctionFeb 2, 2026Unexpected Shutdown

  IT WAS REPORTED THAT DEVICE CAUSED FUSES TO BLOW OFF. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. THE RISK IS:

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24231238 ↗
• MalfunctionJan 27, 2026Output Problem

  IT WAS REPORTED THAT "PRE-OPERATIVELY, AFTER THE SYSTEM STARTUP, AN ERROR MESSAGE APPEARED INDICATING AN ENDOSCOPE FAILURE, DESPITE NO CABLES BEING ATTACHED TO THE FRONT OF THE MODULES. THE MESSAGE ADVISED RESTARTING THE STORZ SYSTEM OR REMOVING THE INSTRUMENTS AND DISCONTINUING THE USE OF THE SYSTEM. THE TEAM RESTARTED THE ENDOSCOPE SYSTEM, AND IT FUNCTIONED PROPERLY THEREAFTER. THERE WAS NO PATIENT INVOLVEMENT." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS-REFERENCE MFR REPORT# 9610617-2026-00132.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24190234 ↗
• MalfunctionJan 26, 2026Output Problem

  IT WAS REPORTED THAT, PRE-OPERATIVELY, WHEN THE TEAM CONNECTED AND TURNED ON THE ENDOSCOPE, A MESSAGE APPEARED STATING, ENDOSCOPE FAILURE, PLEASE RESTART THE ENDOSCOPE AFTER RESTARTING THE ENDOSCOPE, IT WORKED PROPERLY. THERE WAS NO PATIENT INVOLVEMENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. VERSION BB. THE RATIONALE WAS ADJUSTED/CORRECTED AND PRODUCT CODE "FET" AS WELL AS BOTH RELEVANT RISK FILES WERE ADDED AND REVIEWED. THIS LED TO A CHANGE OF THE REPORTING OBLIGATION FROM "NOT REPORTABLE" TO "REPORTABLE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24185686 ↗
• MalfunctionDec 16, 2025Power Problem; Energy Output Problem; Power Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE FUSE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23821177 ↗
• MalfunctionDec 8, 2025Excessive Heating; Excessive Heating

  IT WAS REPORTED: "VERY HOT TIP. RESULT IS DEEP BURN THROUGH 2 LAYERS OF DRAPES". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23735937 ↗
• MalfunctionDec 2, 2025Intermittent Energy Output; Intermittent Energy Output

  THE FOLLOWING WAS REPORTED: " INTERMITTENT LIGHT TURNING ON AND OFF" NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23700751 ↗
• MalfunctionNov 21, 2025Failure to Infuse; Failure to Infuse

  ACCORDING TO THE INFORMATION RECEIVED, BLOW THE FUSES. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622511 ↗
• MalfunctionOct 28, 2025Output Problem; Appropriate Device Problem Term/Code Not Available; Output Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THERE WERE FUNCTION OUTAGES DURING USE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23405882 ↗
• MalfunctionOct 21, 2025Energy Output Problem; Optical Problem; Energy Output Problem; Optical Problem

  IT WAS REPORTED THAT "LIGHT MODULE DEFECTIVE". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23353741 ↗
• MalfunctionSep 5, 2025Electrical /Electronic Property Problem; Energy Output Problem; Electrical /Electronic Property Problem; Energy Output Problem

  ACCORDING TO THE INFORMATION RECEIVED, THE LIGHT SOURCE "KEEP BLOWING FUSES". NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22983855 ↗