n.a. 495NDRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 04048551168899), received between May 7, 2019 and Feb 11, 2026 — classified as 17 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2026Electrical /Electronic Property Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT THEY WERE DOING AN EMERGENCY LAP SURGERY. THEY WERE USING ADAPTER FROM THE RIGID SCOPE TO THE FIBER OPTIC CABLE. THOSE ADAPTERS ONLY HAVE TWO THREADS ON THEM AND THE FIBERT OPTIC CABLE CAME UNDONE AND FELL ON THE DRAPING FOR THE CASE AND CAUGHT FIRE. THEY ARE ASKING TO HAVE THESE THREE ITEMS (SCOPE, IMAGE1S, AND CABLE) EVALUATED TO MAKE SURE THERE ARE NO HEAT, SMOKE, OR OTHER DAMAGED THROUGH THEM. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. PRODUCT 2 CONCOMITANT DEVICE FILED UNDER INTERNAL COMPLAINT ID (B)(4). PRODUCT 3 CONCOMITANT DEVICE FILED UNDER INTERNAL COMPLAINT ID (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24317458 ↗
• InjuryFeb 11, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THEY WERE DOING AN EMERGENCY LAP SURGERY. THEY WERE USING ADAPTER FROM THE RIGID SCOPE TO THE FIBER OPTIC CABLE. THOSE ADAPTERS ONLY HAVE TWO THREADS ON THEM AND THE FIBERT OPTIC CABLE CAME UNDONE AND FELL ON THE DRAPING FOR THE CASE AND CAUGHT FIRE. THEY ARE ASKING TO HAVE THESE THREE ITEMS (SCOPE, IMAGE1S, AND CABLE) EVALUATED TO MAKE SURE THERE ARE NO HEAT, SMOKE, OR OTHER DAMAGED THROUGH THEM. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. PRODUCT 2 CONCOMITANT DEVICE FILED UNDER INTERNAL COMPLAINT ID (B)(4). PRODUCT 3 CONCOMITANT DEVICE FILED UNDER INTERNAL COMPLAINT ID (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24317431 ↗
• MalfunctionJan 5, 2026Detachment of Device or Device Component

  ACCORDING TO THE INFORMATION RECEIVED, STORZ LIGHT CORDS ARE DETACHING FROM THE SCOPE WHILE IN USE. NO INJURY TO PATIENT REPORTED. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23960809 ↗
• MalfunctionJan 5, 2026Detachment of Device or Device Component

  ACCORDING TO THE INFORMATION RECEIVED, STORZ LIGHT CORDS ARE DETACHING FROM THE SCOPE WHILE IN USE, A SCORCH MARK WAS NOTED ON THE DRAPES. NO INJURY TO PATIENT REPORTED. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23960805 ↗
• MalfunctionJan 28, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED DURING A HYSTEROSCOPY WITH MYOSURE AND MIRENA IUD PLACEMENT PROCEDURE, THE LIGHT SOURCE WAS ON A BOOM IN OR, CAMERA AND CORD WERE LYING ACROSS THE PATIENT ON THE BED. ONCE TURNED ON, THE END OF THE CABLE SPARKED, AND THE DRAPE CAUGHT FIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO HARM TO THE PATIENT OR STAFF. CROSS REFERENCE COMPLAINT ID (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21253213 ↗
• MalfunctionDec 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED DURING A MYOMECTOMY (CASE DATA UNKNOWN), THE LIGHT CORD BECAME DISCONNECTED FROM THE SCOP WHILE IN USE, DROPPED ONTO THE DRAPES CAUSED A SMALL BURN ON THE DRAPE HOWEVER, THE PATIENT WAS UNHARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20825172 ↗
• MalfunctionOct 23, 2023Device Handling Problem; Device Handling Problem

  IT WAS REPORTED THAT THE LIGHT CORD BECAME DISCONNECTED FROM THE SCOPE AND CAUSED BURN ON THE DRAPES. TTHE PATIENT WAS NOT HARMED AS IT ONLY BURNED THE DRAPE AND DID NOT PENETRATE THE PATIENT'S SKIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17989930 ↗
• MalfunctionOct 20, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE LIGHT CORD BECAME DISCONNECTED FROM THE SCOPE AND CAUSED BURN ON THE DRAPES. THE PATIENT OR USER WAS NOT HARMED AS IT ONLY BURNED THE DRAPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17981155 ↗
• InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LIGHT SOURCE BEING USED WITH 5MM LAPAROSCOPE AND LIGHT CORD TO PERFORM "SCOPE" SURGERY OF PELVIS. TOWARDS THE END OF THE CASE, THE LIGHT SOURCE UNEXPECTANTLY BECAME DISCONNECTED AND BURNED A HOLE THROUGH THE DRAPES. THIS RESULTED IN 5MM DIAMETER TO PATIENT'S LEFT CHEST.

  Patient problems: Burn(s)

  MAUDE report 17262995 ↗
• InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LIGHT SOURCE BEING USED WITH 5MM LAPAROSCOPE AND LIGHT CORD TO PERFORM "SCOPE" SURGERY OF PELVIS. TOWARDS THE END OF THE CASE, THE LIGHT SOURCE UNEXPECTANTLY BECAME DISCONNECTED AND BURNED A HOLE THROUGH THE DRAPES. THIS RESULTED IN 5MM DIAMETER TO PATIENT'S LEFT CHEST.

  Patient problems: Burn(s)

  MAUDE report 17262969 ↗
• InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT THE END OF THE PROCEDURE (URETERAL STENT PLACEMENT) SURGEON NOTICED THAT THE CYSTOSCOPE LIGHT WENT THROUGH THE DRAPE CAUSING SUPERFICIAL ROUND REDNESS ON THE PATIENT'S SKIN ON THE RIGHT LOWER ABDOMEN, APPROXIMATELY 4MM DIAMETER.

  Patient problems: Burn(s)

  MAUDE report 17262885 ↗
• InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT THE END OF THE PROCEDURE (URETERAL STENT PLACEMENT) SURGEON NOTICED THAT THE CYSTOSCOPE LIGHT WENT THROUGH THE DRAPE CAUSING SUPERFICIAL ROUND REDNESS ON THE PATIENT'S SKIN ON THE RIGHT LOWER ABDOMEN, APPROXIMATELY 4MM DIAMETER.

  Patient problems: Burn(s)

  MAUDE report 17262838 ↗
• InjuryJun 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ELDERLY PATIENT UNDERGOING LAPROSCOPIC HYSTERECTOMY W/ BILATERAL SALPINGO-OOPHORECTOMY AND PELVIC WASHINGS. THE PATIENT WAS PLACED IN LITHOTOMY, PREPPED AND DRAPED. THE TEAM BEGAN TO SET UP THE SCOPE, CAMERA AND LIGHT SOURCE. THE RESIDENT REPORTS FORGETTING TO CONNECT THE LIGHT SOURCE TO THE SCOPE PRIOR TO REQUESTING THE POWER SOURCE MACHINE BE TURNED ON BY THE NURSE. WHILE THE LIGHT SOURCE WAS RESTING OF THE RESIDENT. SHORTLY THEREAFTER, A SMALL HOLE WAS NOTED IN THE DRAPES AND TWO SMALLS (APPROXIMATELY 0.5 CM IN DIAMETER) DARKENED, BLISTERED LESIONS, BELIEVED TO BE 2ND DEGREE BURNS, WERE IDENTIFIED ON THE PATIENT'S RIGHT FOREARM.

  Patient problems: Burn(s)

  MAUDE report 17243565 ↗
• InjuryJun 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ELDERLY PATIENT UNDERGOING LAPROSCOPIC HYSTERECTOMY W/ BILATERAL SALPINGO-OOPHORECTOMY AND PELVIC WASHINGS. THE PATIENT WAS PLACED IN LITHOTOMY, PREPPED AND DRAPED. THE TEAM BEGAN TO SET UP THE SCOPE, CAMERA AND LIGHT SOURCE. THE RESIDENT REPORTS FORGETTING TO CONNECT THE LIGHT SOURCE TO THE SCOPE PRIOR TO REQUESTING THE POWER SOURCE MACHINE BE TURNED ON BY THE NURSE. WHILE THE LIGHT SOURCE WAS RESTING OF THE RESIDENT. SHORTLY THEREAFTER, A SMALL HOLE WAS NOTED IN THE DRAPES AND TWO SMALLS (APPROXIMATELY 0.5 CM IN DIAMETER) DARKENED, BLISTERED LESIONS, BELIEVED TO BE 2ND DEGREE BURNS, WERE IDENTIFIED ON THE PATIENT'S RIGHT FOREARM.

  Patient problems: Burn(s)

  MAUDE report 17238852 ↗
• InjuryJun 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE A LIGHT CABLE FELL OFF SCOPE AND BURNED PATIENT.

  Patient problems: Burn(s)

  MAUDE report 17213135 ↗
• InjuryJun 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE A LIGHT CABLE FELL OFF SCOPE AND BURNED PATIENT.

  Patient problems: Burn(s)

  MAUDE report 17212953 ↗
• InjuryJun 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021 A PATIENT GOT BURNED THROUGH ONE OF OUR LIGHT CABLES. THE OR TEAM LEFT THE LIGHT SOURCE TL400 AT 80% AND PLACED THE LIGHT CORD 495NCSC BY ACCIDENT ON THE PATIENT.

  Patient problems: Burn(s)

  MAUDE report 17210177 ↗
• InjuryJun 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021 A PATIENT GOT BURNED THROUGH ONE OF OUR LIGHT CABLES. THE OR TEAM LEFT THE LIGHT SOURCE TL400 AT 80% AND PLACED THE LIGHT CORD 495NCSC BY ACCIDENT ON THE PATIENT.

  Patient problems: Burn(s)

  MAUDE report 17210176 ↗
• InjuryJun 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CUSTOMERS HAD SEVERAL INCIDENTS INVOLVING THE STORZ LAPAROSCOPIC LIGHT CORDS, RESULTING IN BURNS TO THE PATIENT. THE MAJORITY OF THESE HAVE BEEN THE RESULT OF THE CORD BECOMING DISCONNECTED FROM THE CAMERA ON THE LAPAROSCOPE. PRIOR TO (B)(6) 2020, WE HAD OUTSOURCED CORDS THROUGH A 3RD PARTY. IN (B)(6) 2020 WE BEGAN USING NEW STORZ CORDS. IT SEEMS THE NEW CORDS DO NOT HAVE ENOUGH THREADS AT THE POINT OF CONNECTION. THE NEW CORDS ALSO PROVIDE GREATER LIGHT INTENSITY, WHICH MAY BE CONTRIBUTING TO THE BURNS. THE STORZ REPRESENTATIVE THAT SERVICES THE HOSPITAL HAD BEEN INCLUDED IN DISCUSSIONS REGARDING CONCERNS.

  Patient problems: Burn(s)

  MAUDE report 17210174 ↗
• InjuryJun 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE A LIGHT CABLE FELL OFF SCOPE AND BURNED PATIENT.

  Patient problems: Burn(s)

  MAUDE report 17210172 ↗
• InjuryJun 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CUSTOMERS HAD SEVERAL INCIDENTS INVOLVING THE STORZ LAPAROSCOPIC LIGHT CORDS, RESULTING IN BURNS TO THE PATIENT. THE MAJORITY OF THESE HAVE BEEN THE RESULT OF THE CORD BECOMING DISCONNECTED FROM THE CAMERA ON THE LAPAROSCOPE. PRIOR TO AUGUST 2020, WE HAD OUTSOURCED CORDS THROUGH A 3RD PARTY. IN AUGUST 2020 WE BEGAN USING NEW STORZ CORDS. IT SEEMS THE NEW CORDS DO NOT HAVE ENOUGH THREADS AT THE POINT OF CONNECTION. THE NEW CORDS ALSO PROVIDE GREATER LIGHT INTENSITY, WHICH MAY BE CONTRIBUTING TO THE BURNS. THE STORZ REPRESENTATIVE THAT SERVICES THE HOSPITAL HAD BEEN INCLUDED IN DISCUSSIONS REGARDING CONCERNS.

  Patient problems: Burn(s)

  MAUDE report 17210170 ↗
• InjuryFeb 6, 2023Separation Problem; Separation Problem

  CUSTOMER REPORTED THE PATIENT RECEIVED AN APPROXIMATELY DIME-SIZED BURN TO THE UPPER FOREARM WHEN THE EQUIPMENT (A TELESCOPE ATTACHED TO AN ACTIVE 495ND LIGHT CABLE CONNECTED TO A TL400 LIGHT SOURCE), WAS LAID ON THE PATIENT AND THE LIGHT CABLE BECAME DISCONNECTED FROM THE SCOPE. THE PATIENT REQUIRED WOUND TREATMENT.

  Patient problems: Burn(s)

  MAUDE report 16303702 ↗
• InjuryMay 7, 2019Use of Device Problem; Use of Device Problem

  ALLEGEDLY, DURING A BREAST PROCEDURE, TWO RETRACTORS WITH LIGHT CABLES ATTACHED WERE USED; THE DOCTOR LAID THE RETRACTORS WITH LIGHT CABLES ON THE PATIENT'S CHEST, WHICH CAUSED SECOND DEGREE BURNS TO THE PATIENT. HOSPITAL CONSIDERS THE CAUSE WAS USER ERROR AND FOUND NO FAULT WITH THE LIGHT CABLES OR THE LIGHT SOURCES.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 8587688 ↗