n.a. 495NARecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04048551168868), received between Mar 16, 2023 and Feb 4, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Excessive Heating” (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.

• InjuryFeb 4, 2026Insufficient Device Problem Information; Excessive Heating

  THE FOLLOWING WAS REPORTED: "A MEMBER OF STAFF BURNT THEMSELVES ON THE PROXIMAL END OF THE LIGHT GUIDE CABLE BY HOLDING ONTO THE INSULATED SECTION, CAUSING THE PROXIMAL END TO SWING BACK AND TOUCH THEIR ARM. THIS HAPPENED AROUND 4 WEEKS AGO BUT THE EXACT DATE AND GUIDE CABLE IN USE IS UNKNOWN.

  Patient problems: Burn(s)

  MAUDE report 24260327 ↗
• InjuryJan 30, 2026Excessive Heating

  THE FOLLOWING WAS REPORTED: "A MEMBER OF STAFF BURNT THEMSELVES ON THE PROXIMAL END OF THE LIGHT GUIDE CABLE BY HOLDING ONTO THE INSULATED SECTION, CAUSING THE PROXIMAL END TO SWING BACK AND TOUCH THEIR ARM. THIS HAPPENED AROUND 4 WEEKS AGO BUT THE EXACT DATE AND GUIDE CABLE IN USE IS UNKNOWN.

  Patient problems: Burn(s)

  MAUDE report 24220194 ↗
• InjuryJan 29, 2026Excessive Heating

  IT WAS REPORTED THAT THE LIGHT CABLE WAS RESTING ON THE SURGICAL DRAPE WHILE THE SCOPES WERE BEING CHANGED. HEAT FROM THE CABLE BURNED THROUGH THE DRAPES, RESULTING IN A BURN TO THE PATIENT'S SKIN. SINCE THE PATIENT GOT INJURED, THE CASE IS DEEMED AS REPORTABLE.

  Patient problems: Burn(s)

  MAUDE report 24215230 ↗
• InjuryDec 5, 2025Mechanical Jam; Mechanical Jam

  ACCORDING TO THE INFORMATION RECEIVED, A BILATERAL FLEXIBLE URETEROSCOPY WAS PERFORMED USING A DISPOSABLE FLEXIBLE URETEROSCOPE. DURING INSERTION, THE CABLE ON THE EQUIPMENT STOPPED DEFLECTING AND THE SURGERY HAD TO BE SUSPENDED. ANOTHER PIECE OF EQUIPMENT WAS BROUGHT TO THE TABLE, BUT THE CABLE ON THAT EQUIPMENT ALSO BROKE. THIS DELAYED THE PROCEDURE AND ANOTHER PIECE OF EQUIPMENT HAD TO BE SET UP. ON (B)(6) 2025, IT WAS MENTIONED BY THE CUSTOMER THAT THE WHOLE PROCEDURE HAD TO BE CANCELLED AFTER THE ABOVE-MENTIONED EVENT. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23729889 ↗
• InjuryOct 29, 2024Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT DURING A CYSTOSCOPY ON (B)(6) 2024, THE PATIENT WAS BURNED BY THE LIGHT CORD. THE LIGHT SOURCE WAS ON BUT NOT ATTACHED TO THE SCOPE. THE LIGHT CORD WAS DRAPED ACROSS THE PATIENT AND THEY SUSTAINED A BURN.

  Patient problems: Burn(s)

  MAUDE report 20562204 ↗
• InjuryJun 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A HYSTEROSCOPY AND IUD REMOVAL PROCEDURE ON (B)(6) 2024, THE CABLE WAS FOUND DETACHED FROM THE SCOPE AND WAS LAYING ON TOP OF THE PATIENT. AFTER THE PROCEDURE WAS COMPLETED, A SUPERFICIAL BURN WAS FOUND ON THE PATIENT'S ANTERIOR SIDE. A TOPICAL SOLUTION WAS ADMINISTERED TO TREAT THE SUPERFICAL BURN. THE SCOPE THAT WAS BEING USED WAS A GYNECARE SCOPE, NOT A KARL STORZ SCOPE. THE CABLE WILL NOT BE SENT IN FOR EVALUATION AT THIS TIME PER THE CUSTOMER.

  Patient problems: Burn(s); Superficial (First Degree) Burn

  MAUDE report 19477391 ↗
• InjuryJun 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A HYSTEROSCOPY AND IUD REMOVAL PROCEDURE ON APRIL-30-2024, THE CABLE WAS FOUND DETACHED FROM THE SCOPE AND WAS LAYING ON TOP OF THE PATIENT. AFTER THE PROCEDURE WAS COMPLETED, A SUPERFICIAL BURN WAS FOUND ON THE PATIENT'S ANTERIOR SIDE. A TOPICAL SOLUTION WAS ADMINISTERED TO TREAT THE SUPERFICAL BURN. THE SCOPE THAT WAS BEING USED WAS A GYNECARE SCOPE, NOT A KARL STORZ SCOPE. THE CABLE WILL NOT BE SENT IN FOR EVALUATION AT THIS TIME PER THE CUSTOMER.

  Patient problems: Burn(s)

  MAUDE report 19477387 ↗
• InjuryJun 15, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT AN EVENT WITH THE 495NA FIBER OPTIC CABLE. ACCORDING TO THE INFORMATION RECEIVED, WHILE USING THE LIGHT CABLE ON A PATIENT, THE SCOPE ATTACHED TO THE LIGHT CABLE OVERHEATED INJURING THE PATIENT. PATIENT SUFFERED WHAT APPEARED TO BE THERMAL BURN 1ST DEGREE. PER THE FACILITY THE SCOPE AND LIGHT CABLE WERE USED DURING THE ENTIRE SURGICAL PROCEDURE, APPROXIMATELY 5 HOURS. THE PATIENT SUFFERED WHAT APPEARED TO BE A THERMAL BURN 1ST DEGREE.

  Patient problems: Insufficient Information

  MAUDE report 17136878 ↗
• InjuryMar 16, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  AS PER MEDWATCH REPORT MW5114850 RECEIVED VIA EMAIL: A LAPAROSCOPIC CASE WITH FIBER OPTIC LIGHT CABLE RESULTED IN BURN TO PATIENT. LIGHT CABLE HEATED UP AND TRANSFERRED HEAT TO THE LAPAROSCOPE, RESULTING IN A BURN. THE RECEIVED MEDWATCH REPORT CONTAINED MINIMAL INFORMATION. THE ITEM NUMBER, LOT CODE, FACILITY NAME/LOCATION AND ADDITIONAL PATIENT INFORMATION WAS NOT PROVIDED. WE ARE FILING THIS REPORT REFERENCING A COMMONLY USED FIBER OPTIC LIGHT CABLE, MODEL NUMBER 495NA.

  Patient problems: Burn(s)

  MAUDE report 16553123 ↗