n.a. 495NERecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04048551168905), received between Aug 26, 2019 and Nov 24, 2025 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2025Material Erosion; Overheating of Device; Material Erosion; Overheating of Device

  ACCORDING TO THE INFORMATION RECEIVED, CABLE WAS GETTING TOO HOT AND CONSEQUENTLY END MELTED. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23632907 ↗
• MalfunctionJun 26, 2025Insufficient Device Problem Information; Excessive Heating; Insufficient Device Problem Information; Excessive Heating

  IT WAS REPORTED THAT DURING A ROUTINE POST-OPERATIVE PHYSICIAN VISIT THE DAY AFTER A TUR PROCEDURE, THE PATIENT WAS FOUND TO HAVE SUSTAINED A BURN MEASURING APPROXIMATELY 1X2 CM. THE BURN WAS SUPERFICIAL OVERALL, WITH AN IMPRESSION OF A DEEPER BURN AT ITS CANTER (2 - 3 DEGREE ). NO PERIPHERAL REDNESS OR SIGNIFICANT SWELLING WAS NOTED. THE PATIENT WAS DISCHARGED AS PLANNED WITHOUT ANY DELAY, WITH INSTRUCTIONS FOR LOCAL WOUND CARE. ON FOLLOW-UP TWO DAYS LATER, THE WOUND WAS OBSERVED TO BE HEALING AND CLOSING APPROPRIATELY. THE ASSUMPTION IS THAT THE BURN OCCURRED BECAUSE, FOLLOWING THE SURGERY, THE LIGHT CABLE WAS INADVERTENTLY LEFT ACTIVE AND CAME INTO CONTACT WITH EITHER THE PATIENT OR WITH THE DRAPES COVERING THE PATIENT.

  Patient problems: Bowel Burn

  MAUDE report 22337498 ↗
• MalfunctionFeb 20, 2025Loose or Intermittent Connection; Adverse Event Without Identified Device or Use Problem; Loose or Intermittent Connection; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED: WHILST OPERATING, THE FIBER OPTIC CABLE FALL OFF/COME LOOSE FROM THE LIGHT POST ON THE TELESCOPE. THERE WAS NO HARM TO THE PATIENT OR USER. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21426001 ↗
• InjuryJun 30, 2023Human-Device Interface Problem; Human-Device Interface Problem

  WE WERE NOTIFIED A PATIENT WAS BURNED USING A 5MM SCOPE AND THE 495NE LIGHT CABLE. WE WERE TOLD THE SURGEON DEMANDED THE LARGEST SIZE LIGHT CABLE EVEN THOUGH IT WAS RECOMMENDED TO USE THE SMALLER (495ND) LIGHT CABLE. WE HAVE REQUESTED FURTHER INFO FROM THE CUSTOMER REGARDING PRODUCT, SURGEON AND MORE INFO REGARDING THE INCIDENT, BUT HAVE NOT BEEN GIVE ANY ADDITIONAL DETAILS. THE SCOPE AND LIGHT CABLE WERE NOT TAGGED FOR REPLACEMENT SO CANNOT BE SENT IN. THERE WAS PATIENT INJURY.

  Patient problems: Burn(s)

  MAUDE report 17242744 ↗
• InjuryJun 30, 2023Human-Device Interface Problem; Human-Device Interface Problem

  WE WERE NOTIFIED A PATIENT WAS BURNED USING A 5MM SCOPE AND THE 495NE LIGHT CABLE. WE WERE TOLD THE SURGEON DEMANDED THE LARGEST SIZE LIGHT CABLE EVEN THOUGH IT WAS RECOMMENDED TO USE THE SMALLER (495ND) LIGHT CABLE. WE HAVE REQUESTED FURTHER INFO FROM THE CUSTOMER REGARDING PRODUCT, SURGEON AND MORE INFORMATION REGARDING THE INCIDENT, BUT HAVE NOT BEEN GIVE ANY MORE DETAILS. THE SCOPE AND LIGHT CABLE WERE NOT TAGGED FOR REPLACEMENT SO CANNOT BE SENT IN. THERE WAS PATIENT INJURY.

  Patient problems: Burn(s)

  MAUDE report 17242742 ↗
• InjuryMay 23, 2023Component Incompatible; Overheating of Device; Component Incompatible; Overheating of Device

  IT WAS REPORTED THAT THERE WAS EVENT WITH A 495TIP FIBER OPTIC LIGHT CABLE 330CM,4.8MM. ACCORDING TO THE INFORMATION RECEIVED, THE THICK 495TIP LIGHT CABLE WAS ATTACHED TO A LARYNGOSCOPE LIGHT CARRIER. HEAT WAS GENERATED AT THE LIGHT CARRIER AND LIGHT CABLE CONNECTION AS IT IS NOT THE APPROPRIATE LIGHT CABLE FOR THE LIGHT CARRIER. THE METAL CONNECTOR MUST HAVE BEEN TOUCHING THE PATIENT'S NOSE AS THE PATIENT HAD A BURN ON THE NOSE.

  Patient problems: Burn(s)

  MAUDE report 16989038 ↗
• InjuryApr 14, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THERE WAS EVENT WITH A 495NE 4.8MM X 300 LIGHT CABLE. ACCORDING TO THE INFORMATION RECEIVED THE SURGEON WAS DOING A LAPAROSCOPIC PROCEDURE AND THE SCOPE WAS STILL PARTLY IN THE TROCAR/CANNULA, HOWEVER THE SURGEON LAID THE SCOPE ON THE PATIENT'S ABDOMEN TO GET A BETTER ANGLE OF VIEW TO THE TARGET AREA. EITHER THE SHAFT OF THE SCOPE OR THE LIGHT CABLE JUNCTION TO THE SCOPE'S LIGHT POST THEN CAUSED A PATIENT BURN.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 16742880 ↗
• MalfunctionDec 4, 2020Positioning Failure; Positioning Failure

  PER MEDWATCH REPORT 2200710000-2020-8042, AT THE END OF A LAPAROSCOPIC CHOLECYSTECTOMY WHEN THE OR LIGHTS WERE TURNED ON, IT WAS NOTED BY THE SURGICAL TEAM THE PATIENT HAD RECEIVED A SUPERFICIAL BURN APPROXIMATELY ONE INCH IN DIAMETER THAT APPEARED TO MOST LIKELY ARISE FROM THE LIGHT SOURCE CORD RESTING ON THE PATIENT'S ABDOMEN. THE LIGHT SOURCE CORD AT THE TELESCOPE CONNECTION SITE INTRA OP FELT VERY HOT TO TOUCH AT THE END OF THE PROCEDURE. THE PATIENTS SKIN INURED SITE/AREA WAS CLEANED, BACITRACIN OINTMENT APPLIED, FOLLOWED BY ADAPTIC, AND DRY STERILE DRESSING.

  Patient problems: Patient Problem/Medical Problem; Superficial (First Degree) Burn

  MAUDE report 10945159 ↗
• InjuryAug 26, 2019Use of Device Problem; Use of Device Problem

  ALLEGEDLY, PRIOR TO THE START OF A LAPAROSCOPIC GASTRIC SLEEVE PROCEDURE THE ACTIVE LIGHT CABLE WAS LAID ON THE PATIENT'S ABDOMEN, WHICH CAUSED A 3RD DEGREE BURNS TO THE PATIENT. HOSPITAL CONSIDERS THE CAUSE WAS USER ERROR.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 8933282 ↗