n.a. 495TIPRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04048551004401), received between Nov 22, 2022 and Mar 5, 2025 — classified as 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2025Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  IT WAS REPORTED ON (B)(6) 2025 DURING A LAPAROSCOPY PROCEDURE THE TIP OF THE FIBER OPTIC LIGHT CABLE CAME OFF. NO HARM OR INJURY TO PATIENT REPORTED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE COMPLAINT ID (B)(4).

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

  MAUDE report 21527772 ↗
• MalfunctionMar 5, 2025Break; Detachment of Device or Device Component; Insufficient Device Problem Information; Break; Detachment of Device or Device Component; Insufficient Device Problem Information

  IT WAS REPORTED ON FEBRUARY 12, 2025, DURING A LAPAROSCOPY PROCEDURE, THE TIP OF THE FIBER OPTIC LIGHT CABLE CAME OFF. NO HARM OR INJURY TO PATIENT REPORTED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE COMPLAINT ID (B)(4).

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

  MAUDE report 21527771 ↗
• MalfunctionFeb 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED ON JANUARY 06, 2025 THE COLLAR IS FALLING OFF THE LIGHT CABLE, THERE IS NO INFORMATION THAT THE EVENT CAUSED A HARM OR SERIOUS INJURY TO PATIENT, USER OR THIRD. CROSS REFERENCE MDR: 9610617-2025-00070. CROSS REFERENCE MDR: 9610617-2025-00072. CROSS REFERENCE MDR: 9610617-2025-00073. CROSS REFERENCE MDR: 9610617-2025-00074.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21299968 ↗
• MalfunctionFeb 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED ON JANUARY 06, 2025 THE COLLAR IS FALLING OFF THE LIGHT CABLE, THERE IS NO INFORMATION THAT THE EVENT CAUSED A HARM OR SERIOUS INJURY TO PATIENT, USER OR THIRD. CROSS REFERENCE MDR: 9610617-2025-00070. CROSS REFERENCE MDR: 9610617-2025-00072. CROSS REFERENCE MDR: 9610617-2025-00073. CROSS REFERENCE MDR: 9610617-2025-00075.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21299967 ↗
• MalfunctionFeb 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED ON (B)(6) 2025 THE COLLAR IS FALLING OFF THE LIGHT CABLE, THERE IS NO INFORMATION THAT THE EVENT CAUSED A HARM OR SERIOUS INJURY TO PATIENT, USER OR THIRD. CROSS REFERENCE MDR: 9610617-2025-00070, CROSS REFERENCE MDR: 9610617-2025-00072, CROSS REFERENCE MDR: 9610617-2025-00074, CROSS REFERENCE MDR: 9610617-2025-00075.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21299958 ↗
• MalfunctionFeb 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED ON JANUARY 06, 2025, THE COLLAR IS FALLING OFF THE LIGHT CABLE, THERE IS NO INFORMATION THAT THE EVENT CAUSED A HARM OR SERIOUS INJURY TO PATIENT, USER OR THIRD. CROSS REFERENCE MDR: 9610617-2025-00070, CROSS REFERENCE MDR: 9610617-2025-00073, CROSS REFERENCE MDR: 9610617-2025-00074, CROSS REFERENCE MDR: 9610617-2025-00075.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21299957 ↗
• MalfunctionFeb 3, 2025Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED ON JANUARY 06, 2025 THE COLLAR IS FALLING OFF THE LIGHT CABLE, THERE IS NO INFORMATION THAT THE EVENT CAUSED A HARM OR SERIOUS INJURY TO PATIENT, USER OR THIRD. CROSS REFERENCE MDR: 9610617-2025-00072, CROSS REFERENCE MDR: 9610617-2025-00073, CROSS REFERENCE MDR: 9610617-2025-00074, CROSS REFERENCE MDR: 9610617-2025-00075.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21299954 ↗
• InjuryJul 19, 2024Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT DURING A LAP HIATAL HERNIA REPAIR PROCEDURE ON (B)(6) 2024, THE SURGICAL TECHNICIAN (CST) WAS HOLDING THE TIPCAM WHERE THE LIGHT CORD PLUGS INTO THE PROXIMAL END OF THE SCOPE. THE CST BURNED HER FINGER ON THE JUNCTION WHERE THE LIGHT CORD ATTACHES TO THE LIGHT SOURCE. THIS CAUSED A SLIGHT SKIN DISCOLORATION ON HER FINGER, AND NO TREATMENT WAS DEEMED NECESSARY THEN. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITHOUT ANY FURTHER INCIDENTS. ACCORDING TO THE CUSTOMER, THE CST IS DOING FINE NOW.

  Patient problems: Burn(s)

  MAUDE report 19785983 ↗
• InjuryMay 2, 2024Overheating of Device; Excessive Heating; Overheating of Device; Excessive Heating

  IT WAS REPORTED THAT DURING A LAP HIATAL HERNIA REPAIR PROCEDURE ON (B)(6)2024, THE SURGICAL TECHNICIAN (CST) WAS HOLDING THE TIPCAM WHERE THE LIGHT CORD PLUGS INTO THE PROXIMAL END OF THE SCOPE. THE CST BURNED HER FINGER ON THE JUNCTION WHERE THE LIGHT CORD ATTACHES TO THE LIGHT SOURCE. THIS CAUSED A SLIGHT SKIN DISCOLORATION ON HER FINGER, AND NO TREATMENT WAS DEEMED NECESSARY THEN. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITHOUT ANY FURTHER INCIDENTS. ACCORDING TO THE CUSTOMER, THE CST IS DOING FINE NOW.

  Patient problems: Burn(s); Skin Burning Sensation

  MAUDE report 19234507 ↗
• InjuryDec 1, 2022Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE PRODUCT (495TIP - FIBER OPTIC LIGHT CABLE, 300CM, Ø4,8MM). DURING OUR INVESTIGATION OF A PATIENT BURN INCIDENT THAT OCCURRED DURING A LAP CHOLE CASE, THE CUSTOMER MENTIONED SHE WAS TOLD THAT THE EXACT SAME TYPE OF BURN HAD OCCURRED DURING A PREVIOUS LAP CHOLE CASE THE WEEK PRIOR (AN APPROXIMATELY DIME-SIZED BURN BELOW THE BELLY BUTTON). CUSTOMER ALSO BELIEVES THAT IN THIS CASE, THE BURN REDDENED AND IT DIDN'T BLISTER BUT WAS UNABLE TO OBTAIN ANY FURTHER DETAILS ABOUT THIS PREVIOUS CASE. THIS COMPLAINT INVOLVES A TOTAL OF 3 ITEMS (COMPLAINT NUMBERS: (B)(4), (B)(4), (B)(4) OF WHICH (B)(4) IS PROBABLY THE CAUSE OF THE BURN. THE ASSOCIATED DEVICES ARE MENTIONED IN CONCOMITANT MEDICAL PRODUCTS.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 15894363 ↗
• InjuryNov 22, 2022Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE PRODUCT (495TIP - FIBER OPTIC LIGHT CABLE, 300CM, Ø4,8MM). ACCORDING TO THE COMPLAINT DESCRIPTION, THE PATIENT WAS BURNED DURING SURGERY USING THE LIGHT SOURCE (LIGHT SOURCE WAS SET AT 80%), CAUSING A SHORT DELAY. PER THE CUSTOMER, THE SCOPE WITH ACTIVE LIGHT CABLE CONNECTED WAS NOT LAID ON THE PATIENT, AND THE BURN OCCURRED DURING USE. CUSTOMER WASN'T SURE IF IT HAD SOMETHING TO DO WITH THE PATIENT'S SIZE. THE BURN SIZE WAS A LITTLE LARGER THAN A DIME AND OCCURRED RIGHT BELOW THE BELLY BUTTON. THE BURN REDDENED, AND IT DIDN'T BLISTER. IT WAS TREATED WITH A TEFLA PAD OVER THE BURN AREA. PER THE CUSTOMER, THE PATIENT IS DOING FINE, AND NO FURTHER TREATMENT WAS NECESSARY. THIS COMPLAINT INVOLVES A TOTAL OF 3 ITEMS (COMPLAINT NUMBERS: (B)(4) OF WHICH (B)(4) IS PROBABLY THE CAUSE OF THE BURN. THE ASSOCIATED DEVICES ARE MENTIONED.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 15849425 ↗