NA 05-0094l-nirRecalls & reported problems
SCHÖLLY FIBEROPTIC GmbH · NIR FI Light Guide, 4.8 x 3000 mm · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04250480109038), received between Nov 6, 2024 and Mar 19, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Temperature Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Temperature Problem4
- Material Split, Cut or Torn1
- Thermal Decomposition of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 19, 2026Temperature Problem
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE LIGHT CORD FOR THE NEAR INFRARED (NIR) HANDHELD CAMERA GOT REALLY HOT. THE CALLER MENTIONED THAT AT THE END OF THE CASE, THERE WAS SMOKE COMING FROM THE LIGHT CORD, AND ONE SIDE WAS COMPLETELY BURNED. THE CALLER WAS UNSURE HOW LONG THE LIGHT WAS LEFT ON FOR, BUT INDICATED THEY HAD TURNED OFF THE LIGHT CORD EARLIER IN THE PROCEDURE. THEY INFORMED THEY WOULD TAKE THIS LIGHT CORD OUT OF ROTATION. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24641369 ↗MalfunctionFeb 27, 2026Material Split, Cut or Torn
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24474407 ↗MalfunctionFeb 12, 2026Temperature Problem
IT WAS REPORTED THAT DURING THE CASE, THE HANDHELD CAMERA LIGHT GUIDE CORD WAS HEATING UP AND BEGINNING TO MELT ITEMS AT THE TIP. THERE WAS A DARK SPOT OBSERVED ON BOTH ENDS OF THE LIGHT CORD. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS COMPLETED WITH THE SAME SYSTEM. THE LIGHT GUIDE WAS THE ONLY ITEM CHANGED OUT DUE TO SMOKING FROM THE TIP OF THE LIGHT CORD. NO HARM OR INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24319902 ↗MalfunctionMar 12, 2025Temperature Problem; Temperature Problem
IT WAS REPORTED THAT DURING A DA VINCI ASSISTED SURGICAL PROCEDURE, IT WAS NOTED THAT BOTH THE ENDS OF THE CORD GOT BURNED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INITIAL REPORTER CONFIRMED THE ISSUE CAUSE ANY INJURY/HARM TO THE PATIENT /OR STAFF. THE ISSUE DID NOT CAUSE ANY DAMAGE TO DRAPE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21587194 ↗MalfunctionNov 6, 2024Thermal Decomposition of Device; Temperature Problem; Thermal Decomposition of Device; Temperature Problem
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20625547 ↗
Other Source, Carrier, Fiberoptic Light devices
- PILLING IPN025440Teleflex Incorporated · SOURCE, CARRIER, FIBEROPTIC LIGHT1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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