SafeLight 0233050400Recalls & reported problems
Stryker Corporation · Fiber Optic Cable with Advanced Imaging Modality · Class 2
All models of SafeLight (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Stryker SafeLight fiber optic light cord is used with endoscopy towers to illuminate the inside of the body during surgery. The 55 reports mostly describe the cable failing to light properly or shutting off mid-procedure, flickering, and getting hot enough to burn the light cord itself or the patient, including one report of a burn after the scope came off the cord and the safety shutoff failed. There are no deaths and no injuries reported, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 56
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 07613327462777), received between Jul 27, 2021 and Sep 10, 2026 — classified as 56 malfunctions.
The most frequently reported specific device problem is “Output Problem” (37 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Output Problem37
- Optical Problem23
- Temperature Problem9
- Overheating of Device7
- Electrical Power Problem2
- Intermittent Energy Output2
- Adverse Event Without Identified Device or Use Problem1
- Continuous Firing1
Patient problems
- No Clinical Signs, Symptoms or Conditions48
- Insufficient Information6
- Burn(s)5
- Superficial (First Degree) Burn2
Recent adverse event reports
The 25 most recent of 56 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2026Overheating of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50725009 ↗MalfunctionAug 28, 2026Optical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50500585 ↗MalfunctionAug 17, 2026Overheating of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50288688 ↗MalfunctionAug 6, 2026Overheating of Device
Patient problems: Burn(s)
MAUDE report 50165965 ↗MalfunctionMay 21, 2026Overheating of Device; Electrical Shorting
IT WAS REPORTED THAT LIGHT CABLE DID NOT TURN OFF WHEN ADAPTER/SCOPE WAS REMOVED CAUSING A BURN ON THE PATIENT. FIRST DEGREE BURN TO PATIENT.
Patient problems: Burn(s); Superficial (First Degree) Burn
MAUDE report 25248513 ↗MalfunctionNov 21, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT BURN OCCURRED ON LIGHT CORD, DURING PROCEDURE. POWER WAS NOT ON AND DEVICE HAD BEEN OFF FOR SOME TIME. AND THERE WAS SMOKE IN THE ROOM. PROCEDURE COMPLETED USING ROBOTIC PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23619840 ↗MalfunctionOct 30, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THERE WAS AN OUT OF BOX FAILURE FOR QUANTITY 1 SAFELIGHT OPTIC CORD. THEY WENT LIVE WITH THE NEW EQUIPMENT A WEEK OR TWO AGO AND THE ATTACHED LIGHT CORD DOESN¿T TURN OFF WHEN DISCONNECTED FROM THE SAFELIGHT ADAPTER. THEY HAVE TRIED OTHER LIGHT CORDS / LIGHT SOURCES / ADAPTERS TO NARROW THE CHALLENGE TO THIS LIGHT CORD. THEREFORE, THERE WAS A THERMAL EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23425762 ↗MalfunctionAug 4, 2025Optical Problem; Output Problem; Optical Problem; Output Problem
IT WAS REPORTED THAT THE SAFELIGHT CABLE WAS FLICKERING AND THAT THERE WAS 5 MINUTES OF LOSS OF LIGHT. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22708418 ↗MalfunctionJun 25, 2025Optical Problem; Output Problem; Optical Problem; Output Problem
IT WAS REPORTED BY THE CUSTOMER THAT "DURING DISSECTION ON A LAPAROSCOPIC HYSTERECTOMY, THE STRYKER TOWER ANNOUNCED "LIGHT SOURCE DEACTIVATED". IT THEN CONTINUED TO STROBE BETWEEN ON AND OFF, ALTERNATING SAYING "LIGHT SOURCE ACTIVATED AND LIGHT SOURCE DEACTIVATED". GYNE CHARGE NURSE WAS QUICKLY RETRIEVED FOR THE SITUATION. A NEW TOWER AND CAMERA AND LAPAROSCOPE WERE QUICKLY ACQUIRED, BUT AFTER HOOKING THEM UP, THE SAME PROBLEM OCCURRED. THE TEAM THEN TRIED A NEW LIGHT CORD, AND THIS FIXED THE PROBLEM. THE LIGHT CORD WAS ISOLATED IN A ZIPLOC BAG WITH A NOTE TO RETURN IT TO THE CNL UPON CLEANING". THEREFORE, THERE WAS LOSS OF LIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22332862 ↗MalfunctionApr 9, 2025Overheating of Device; Temperature Problem; Overheating of Device; Temperature Problem
IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.
Patient problems: Insufficient Information
MAUDE report 21809408 ↗MalfunctionApr 3, 2025Temperature Problem; Temperature Problem
IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21767234 ↗MalfunctionFeb 10, 2025Temperature Problem; Temperature Problem
IT WAS REPORTED THAT THERE WAS A THERMAL EVENT THAT RESULTED IN A 2ND DEGREE BURN.
Patient problems: Burn(s)
MAUDE report 21345918 ↗MalfunctionJan 14, 2025Output Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: Insufficient Information
MAUDE report 21154285 ↗MalfunctionJan 14, 2025Output Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: Insufficient Information
MAUDE report 21154133 ↗MalfunctionDec 27, 2024Electrical Power Problem; Output Problem; Temperature Problem; Electrical Power Problem; Output Problem; Temperature Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT AND A THERMAL EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21028043 ↗MalfunctionDec 18, 2024Temperature Problem; Temperature Problem
MalfunctionDec 16, 2024Output Problem; Output Problem
IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20939341 ↗MalfunctionDec 4, 2024Output Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20846644 ↗MalfunctionSep 17, 2024Electrical Power Problem; Output Problem; Electrical Power Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20241765 ↗MalfunctionJun 5, 2024Temperature Problem; Temperature Problem
MalfunctionMay 16, 2024Continuous Firing; Temperature Problem; Continuous Firing; Temperature Problem
IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19337563 ↗MalfunctionApr 25, 2024Output Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19181722 ↗MalfunctionOct 6, 2023Optical Problem; Optical Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17890119 ↗MalfunctionOct 5, 2023Optical Problem; Optical Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17876262 ↗MalfunctionOct 5, 2023Optical Problem; Optical Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17876248 ↗
Other Confocal optical imaging devices
- HD 3CMOS AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S200-XZ-EAOlympus Medical Systems Corp. · Confocal Optical Imaging1,110 reports
- VISERA ELITE II VIDEO SYSTEM CENTER OLYMPUS OTV-S200Olympus Medical Systems Corp. · Confocal Optical Imaging870 reports
- HD 3CMOS CAMERA HEAD OLYMPUS CH-S200-XZ-EBOlympus Medical Systems Corp. · Confocal Optical Imaging698 reports
- L11 0220230300Stryker Corporation · Confocal optical imaging233 reports
- L10 0220220300Stryker Corporation · Confocal optical imaging77 reports
- AIM SafeLight 0233050300Stryker Corporation · Confocal optical imaging62 reports
- 1588 AIM 1588010000Stryker Corporation · Confocal optical imaging35 reports
- 1588 AIM 1588020122Stryker Corporation · Confocal optical imaging26 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page