n.a. 495NCSCRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 04048551290545), received between Jul 13, 2017 and Sep 17, 2026 — classified as 13 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (7 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Excessive Heating

  It was reported that patient was burned during procedure. There is no information available on the severity of the burn injury and if medical intervention was required.

  Patient problems: Burn(s)

  MAUDE report 50809832 ↗
• InjurySep 17, 2026Excessive Heating

  Patient problems: Burn(s)

  MAUDE report 50809831 ↗
• InjuryFeb 25, 2026Overheating of Device

  ACCORDING TO THE INFORMATION RECEIVED, DURING A SURGERY (PARATHYROIDECTOMY VIA LAPAROSCOPY), THROUGH THE TECHNIQUE HE USED TO ACCESS THE ANATOMICAL AREA BEING OPERATED ON, IT WAS OBSERVED THAT INSIDE THE PATIENT, AT THE LEVEL OF THE NECK OVER THE LARYNGEAL REGION, THE SCOPE (10 MM / 30° LENS) WAS RESTING ON THE TISSUE. THIS WAS DONE TO CREATE SPACE SO THAT THE FORCEPS COULD ALSO BE INSERTED AND WORK ON THE SURGICAL AREA. AT THE END OF THE PROCEDURE, A LESION ON THE NECK TISSUE BEGAN TO APPEAR.

  Patient problems: Burn(s)

  MAUDE report 24445511 ↗
• InjuryJan 28, 2026Overheating of Device

  ACCORDING TO THE INFORMATION RECEIVED, DURING A SURGERY (PARATHYROIDECTOMY VIA LAPAROSCOPY), THROUGH THE TECHNIQUE HE USED TO ACCESS THE ANATOMICAL AREA BEING OPERATED ON, IT WAS OBSERVED THAT INSIDE THE PATIENT, AT THE LEVEL OF THE NECK OVER THE LARYNGEAL REGION, THE SCOPE (10 MM / 30° LENS) WAS RESTING ON THE TISSUE. THIS WAS DONE TO CREATE SPACE SO THAT THE FORCEPS COULD ALSO BE INSERTED AND WORK ON THE SURGICAL AREA. AT THE END OF THE PROCEDURE, A LESION ON THE NECK TISSUE BEGAN TO APPEAR.

  Patient problems: Burn(s)

  MAUDE report 24198586 ↗
• InjuryDec 19, 2025Overheating of Device; Overheating of Device

  ACCORDING TO THE INFORMATION RECEIVED, AT THE END OF THE PROCEDURE, CUSTOMER TURNED OFF LIGHT SOURCE AND GAS, THEN SET THE CABLE DOWN ON THE DRAPE ON TOP OF THE PATIENT. THE SILVER RING ON CORD GOT HOT AND BURNED PATIENT THE SIZE OF A DIME ON ABDOMEN, AND THE BURN GOT TREATED RIGHT AWAY. NO FURTHER INJURY REPORTED.

  Patient problems: Burn(s)

  MAUDE report 23849370 ↗
• InjuryDec 19, 2025Overheating of Device; Overheating of Device

  ACCORDING TO THE INFORMATION RECEIVED, AT THE END OF THE PROCEDURE, CUSTOMER TURNED OFF LIGHT SOURCE AND GAS, THEN SET THE CABLE DOWN ON THE DRAPE ON TOP OF THE PATIENT. THE SILVER RING ON CORD GOT HOT AND BURNED PATIENT THE SIZE OF A DIME ON ABDOMEN, AND THE BURN GOT TREATED RIGHT AWAY. NO FURTHER INJURY REPORTED.

  Patient problems: Burn(s)

  MAUDE report 23849360 ↗
• MalfunctionSep 11, 2025Decoupling; Material Separation; Decoupling; Material Separation

  IT WAS REPORTED THE END OF THE CABLES FALLS OFF OF THEM AS A RESULT OF A DEFICIENCY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE THE FOLLOWIG MEDWATCH NUMBERS: 9510617-2025-01588, 9610617-2025-01589 AND 9610617-2025-01582.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23033206 ↗
• MalfunctionSep 11, 2025Decoupling; Material Separation; Unspecified Valve Regurgitation; Decoupling; Material Separation; Unspecified Valve Regurgitation

  IT WAS REPORTED THE END OF THE CABLES FALLS OFF OF THEM AS A RESULT OF A DEFICIENCY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE THE FOLLOWIG MEDWATCH NUMBERS: (B)(4), 96105-2025-01590 AND 9610617-2025-01582.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23033184 ↗
• MalfunctionSep 11, 2025Decoupling; Material Separation; Decoupling; Material Separation

  IT WAS REPORTED THE END OF THE CABLES FALLS OFF OF THEM AS A RESULT OF A DEFICIENCY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE THE FOLLOWIG MEDWATCH NUMBERS: 9610617-2025-01589, 96105-2025-01590 AND 9610617-2025-01582.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23033136 ↗
• MalfunctionSep 10, 2025Decoupling; Detachment of Device or Device Component; Decoupling; Detachment of Device or Device Component

  IT WAS REPORTED THE END OF THE FIBER OPTIC LIGHT CABLES FALLS OFF. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE THE FOLLOWING MEDWATCH NUMBERS: 9610617-2025-0158896, 9610617-2025-01589 AND 96105-2025-01590.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23019743 ↗
• MalfunctionMar 26, 2025Overheating of Device; Device Handling Problem; Overheating of Device; Device Handling Problem

  IT WAS REPORTED THAT THE STORZ SYSTEM LIGHT SOURCE USED IN THIS CASE WAS STILL ON FROM A PRIOR CASE, HAD BEEN PLACED ON THE MAYO STAND, AND WHILE THE TEAM WAS PRESENT THE LIGHT SOURCE FELL FROM THE MAYO STAND ONTO THE DRAPE. THE PHYSICIAN ASSISTANT NOTICED THIS AND IMMEDIATELY PULLED THE LIGHT SOURCE AWAY FROM THE DRAPE, BUT NOT BEFORE NOTICING A SMALL BURN. THE PATIENT WAS UNHARMED, UNDERWENT THE PROCEDURE, AND ULTIMATELY WAS DISCHARGED IN GOOD CONDITION. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21700789 ↗
• MalfunctionJan 30, 2025Fracture; Mechanical Problem; Fracture; Mechanical Problem

  IT WAS REPORTED THAT SHEATH IS TORN - DURING USE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21274742 ↗
• InjuryOct 29, 2024Insufficient Device Problem Information; Excessive Heating; Insufficient Device Problem Information; Excessive Heating

  IT WAS REPORTED THAT A PATIENT WAS BURNED DURING A CASE. PATIENT HAD A BLISTER SECOND DEGREE BURN.

  Patient problems: Burn(s)

  MAUDE report 20561507 ↗
• InjuryOct 29, 2024Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT A PATIENT WAS BURNED DURING A CASE. PATIENT HAD A BLISTER SECOND DEGREE BURN.

  Patient problems: Burn(s)

  MAUDE report 20561348 ↗
• InjurySep 27, 2024Overheating of Device; Patient Device Interaction Problem; Overheating of Device; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING PROCEDURE ON (B)(6) 2024, THE SCOPE THAT WAS CONNECTED TO THE LIGHT CABLE BURNED THE PATIENT FROM THE HUB/NECK OF THE SCOPE WHERE THE LIGHT CORD ATTACHES. NO FURTHER INFORMATION IS AVAILABLE, OTHER THAN NO STAFF WAS HARMED, AND NO DELAY TO THE PROCEDURE.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 20328662 ↗
• InjurySep 27, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING PROCEDURE ON (B)(6) 2024, THE SCOPE THAT WAS CONNECTED TO THE LIGHT CABLE BURNED THE PATIENT FROM THE HUB/NECK OF THE SCOPE WHERE THE LIGHT CORD ATTACHES. NO FURTHER INFORMATION IS AVAILABLE, OTHER THAN NO STAFF WAS HARMED, AND NO DELAY TO THE PROCEDURE.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 20328581 ↗
• 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 17210171 ↗
• 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 17210169 ↗
• InjuryJul 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALLEGEDLY, THE DOCTOR LAID A SCOPE WHICH WAS CONNECTED TO A CAMERA AND ATTACHED TO AN ACTIVE LIGHT CABLE ON THE PATIENT'S BARE SKIN; THE PATIENT RECEIVED A BURN. THE HOSPITAL PROVIDED NO FURTHER INFORMATION.

  Patient problems: Burn, Thermal

  MAUDE report 6712536 ↗