n.a. TL300Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04048551378830), received between Jun 29, 2022 and Jul 21, 2026 — classified as 6 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (2 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.

• InjuryJul 21, 2026Output Problem

  IT WAS REPORTED THAT PRIOR TO SURGERY, THE LIGHT SOURCE TURNED OFF AUTOMATICALLY IMMEDIATELY AFTER BEING POWERED ON. THE STORZ SYSTEM WAS RESTARTED; HOWEVER, THE ISSUE PERSISTED. BECAUSE THE ISSUE COULD NOT BE RESOLVED DESPITE TROUBLESHOOTING ATTEMPTS, THE SURGERY WAS CONVERTED TO A LAPAROSCOPIC APPROACH. PATIENT INVOLVEMENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 25895006 ↗
• MalfunctionJun 8, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING SURGERY, A FROZEN IMAGE ERROR WAS TRIGGERED WHILE USING THE 30-DEGREE ENDOSCOPE. LATER IN THE PROCEDURE, THE ISSUE OCCURRED AGAIN, AND A HORIZONTAL LINE APPEARED ACROSS THE MIDDLE OF THE SCREEN AND THE LIGHT SOURCE WAS LOST. THE SURGICAL TEAM SWITCHED TO A 0-DEGREE ENDOSCOPE BECAUSE IT WAS MORE ADVANTAGEOUS TO THE PROCEDURE, WHICH WORKED WITHOUT ANY PROBLEMS. AFTER ATTEMPTING TO SWITCH BACK TO THE 30-DEGREE ENDOSCOPE, THERE WAS NO IMAGE DISPLAYED AT ALL, SO THE SURGICAL TEAM CONTINUED USING THE 0-DEGREE ENDOSCOPE. THE MONITORS WERE STILL SHOWING THAT THE 30-DEGREE ENDOSCOPE WAS CONNECTED EVEN AFTER IT HAD BEEN SWITCHED WITH THE 0-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 25435312 ↗
• MalfunctionDec 30, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC RIGHT NEPHRECTOMY DURING THE SUPERIOR ASPECT OF THE RIGHT KIDNEY MOBILIZATION, ALL SCREENS BLACKED OUT ON THE TOWER AND SURGEON CONSOLE. WHEN CHECKING THE ENDOSCOPE SYSTEM, THE LIGHT SOURCE WAS FLASHING AND THERE WAS A BURNING SMELL. THE OPERATING ROOM TEAM REMOVED ALL INSTRUMENTS, UNDOCKED THE SYSTEM, AND MOVED THE ROBOTIC ARMS AWAY FROM THE PATIENT TO SAFELY SHUT DOWN THE SYSTEM. WHEN THE SYSTEM WAS RESTARTED, THE ISSUE RECURRED ALONG WITH THE BURNING SMELL. THE SURGEON CONVERTED THE SURGERY TO A LAPAROSCOPIC SURGERY TO AVOID FURTHER INCIDENT. IT WAS FOUND THE KARL STORZ HARDWARE WAS SMOKING INSIDE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23931022 ↗
• MalfunctionDec 5, 2025Loose or Intermittent Connection; No Apparent Adverse Event; Loose or Intermittent Connection; No Apparent Adverse Event

  IT WAS REPORTED THAT THE "THE TOWER TRIGGERED AN ENDOSCOPE ERROR". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR: 9610617-2025-02249. 9610617-2025-02250.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23730162 ↗
• MalfunctionOct 15, 2025Fire; Excessive Heating; Fire; Excessive Heating

  IT WAS REPORTED THAT DURING SURGERY, WHEN THE OBJECTIVE END OF THE ENDOSCOPE WAS PLACED STATIONARY ON THE PATIENT'S BODY, THE HEAT RAPIDLY BURNED THROUGH THE NON-WOVEN FABRIC. THE STANDBY BUTTON OF THE COLD LIGHT SOURCE HAD NOT BEEN PRESSED AT THE TIME. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23280778 ↗
• InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INFORMATION RECEIVED, THE USER TEMPORARILY PLACED THE GUIDE BEAM AND LENS ON THE PATIENT DURING THE OPERATION. AFTER THE OPERATION, IT WAS FOUND THAT THE PATIENT WAS SLIGHTLY SCALDED ON THE SKIN WHERE IT HAD BEEN PLACED. AFTER THE SCALDING OBSERVATION FOR A PERIOD OF TIME, NO OTHER ABNORMALITIES WERE FOUND, AND NO ADDITIONAL INTERVENTION WAS DONE.

  Patient problems: Burn(s)

  MAUDE report 21537905 ↗
• InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE INFORMATION RECEIVED, THE USER TEMPORARILY PLACED THE GUIDE BEAM AND LENS ON THE PATIENT DURING THE OPERATION. AFTER THE OPERATION, IT WAS FOUND THAT THE PATIENT WAS SLIGHTLY SCALDED ON THE SKIN WHERE IT HAD BEEN PLACED. AFTER THE SCALDING OBSERVATION FOR A PERIOD OF TIME, NO OTHER ABNORMALITIES WERE FOUND, AND NO ADDITIONAL INTERVENTION WAS DONE.

  Patient problems: Burn(s)

  MAUDE report 21531987 ↗
• MalfunctionNov 22, 2024Intermittent Communication Failure; Intermittent Communication Failure

  IT WAS REPORTED THAT DURING THE PROCEDURE THE PICTURE OF THE CAMERA IS GONE. AFTER A SHORT PERIOD, THE PICTURE IS BACK. NO HARM TO PATIENT, USER OR THIRD REPORTED. NO NEGATIVE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20760012 ↗
• InjuryOct 15, 2024Optical Problem; Optical Problem

  IT WAS REPORTED THAT PRE-OPERATIVELY, THE STORZ SYSTEM FAILED TO PERFORM A WHITE BALANCE. THE TROUBLESHOOTING INVOLVED RESTARTING THE STORZ SYSTEM THREE TIMES, CHANGING THREE ENDOSCOPES, DISCONNECTING THE EXTENSION CABLE, AND CONNECTING THE ENDOSCOPES WITHOUT THE EXTENSION CABLE. DESPITE THESE EFFORTS, THE ISSUE PERSISTED. A SYSTEM REBOOT WAS ALSO ATTEMPTED, BUT THE ISSUE REMAINED UNRESOLVED. AS A RESULT, THE ROBOTIC SURGERY WAS CONVERTED TO LAPAROSCOPIC SURGERY, AND THE NEXT SCHEDULED OPERATION WAS CANCELLED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20453807 ↗
• InjuryAug 26, 2022Use of Device Problem; Use of Device Problem

  CUSTOMER REPORTED THAT ON OR ABOUT (B)(6) 2022, A PATIENT BURN OCCURRED AS A RESULT OF THE LIGHT SOURCE NOT BEING TURNED OFF OR ON STANDBY WHILE CAMERA (SCOPE, LIGHT CABLE) WAS LAYING ON THE PATIENT OR PATIENT DRAPE DURING A CYSTO CASE. TO DATE, WE HAVE BEEN UNABLE TO OBTAIN ANY FURTHER DETAILS ON THIS CASE.

  Patient problems: Burn(s)

  MAUDE report 15300713 ↗
• InjuryJun 29, 2022Use of Device Problem; Use of Device Problem

  AS PER MANUFACTURER INCIDENT REPORT #(B)(4) RECEIVED FROM THE FACTORY IN (B)(6): THE REPORTED EVENT HAPPENED IN (B)(6). TOWARDS THE END OF A THORAX SURGERY, THE SURGEON PLACED THE TELESCOPE NEAR THE PATIENT'S FACE WHILE THE LIGHT SOURCE WAS ON. AFTER A SHORT TIME, THE ANESTHETIST NOTICED THAT THERE WAS A SLIGHT BURN IN THE SHEET. THIS CAUSED A SLIGHT BURN NEAR THE PATIENT'S CHIN. THE PATIENT WAS TREATED WITH AN APPROPRIATE OINTMENT.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 14852572 ↗