AIM SafeLight 0233050300Recalls & reported problems
Stryker Corporation · Fiber Optic Cable · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Stryker AIM SafeLight fiber optic cable is used for confocal optical imaging inside the body. The 62 reports mostly describe the cable tip heating up during use, sometimes with burns noted on the patient, along with loss of image or light output and failures to shut off. There are 2 injuries and no deaths. 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
- 62
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 07613327051674), received between Jan 25, 2019 and Aug 28, 2024 — classified as 2 injuries, 60 malfunctions.
The most frequently reported specific device problem is “Output Problem” (27 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 Problem27
- Temperature Problem9
- Failure to Shut Off8
- Thermal Decomposition of Device6
- Adverse Event Without Identified Device or Use Problem5
- No Display/Image5
- Activation Failure4
- Contamination /Decontamination Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions47
- No Known Impact Or Consequence To Patient14
- Insufficient Information8
- Burn(s)4
- Burn, Thermal2
- Superficial (First Degree) Burn2
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 62 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2024Temperature Problem; Temperature Problem
IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20091304 ↗MalfunctionAug 23, 2024Failure to Shut Off; Temperature Problem; Failure to Shut Off; Temperature Problem
IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20054878 ↗MalfunctionJul 10, 2024Failure to Shut Off; Temperature Problem; Failure to Shut Off; Temperature Problem
IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19715946 ↗MalfunctionMar 12, 2024Output Problem; Output Problem
IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18890811 ↗MalfunctionMar 12, 2024Output Problem; Output Problem
IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18890809 ↗MalfunctionFeb 28, 2024Use of Device Problem; Temperature Problem; Use of Device Problem; Temperature Problem
IT WAS REPORTED THAT THERE WAS THERMAL EVENT.
Patient problems: Burn(s); No Clinical Signs, Symptoms or Conditions
MAUDE report 18803893 ↗MalfunctionFeb 7, 2024Output Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18662022 ↗MalfunctionFeb 7, 2024Output Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18662021 ↗MalfunctionJan 25, 2024Output Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18581745 ↗MalfunctionJan 25, 2024Output Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18580553 ↗MalfunctionJan 25, 2024Output Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18580411 ↗MalfunctionJan 25, 2024Output Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18580409 ↗MalfunctionJan 25, 2024Output Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18580353 ↗MalfunctionJan 25, 2024Output Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18580346 ↗MalfunctionJan 25, 2024Output Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18580232 ↗MalfunctionJan 25, 2024Output Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18580231 ↗MalfunctionJan 25, 2024Output Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18580229 ↗MalfunctionJan 25, 2024Output Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18580228 ↗MalfunctionJan 25, 2024Output Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18580226 ↗MalfunctionJan 25, 2024Output Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18580223 ↗MalfunctionJan 25, 2024Output Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18580118 ↗MalfunctionDec 22, 2023Connection Problem; Temperature Problem; Connection Problem; Temperature Problem
IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18388602 ↗MalfunctionNov 17, 2023Output Problem; Activation Failure; Output Problem; Activation Failure
IT WAS REPORTED THE THERE WAS LOSS OF LIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18163073 ↗MalfunctionNov 17, 2023Output Problem; Activation Failure; Output Problem; Activation Failure
IT WAS REPORTED THE THERE WAS LOSS OF LIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18163062 ↗MalfunctionNov 17, 2023Output Problem; Activation Failure; Output Problem; Activation Failure
IT WAS REPORTED THE THERE WAS LOSS OF LIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18162721 ↗
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
- SafeLight 0233050400Stryker Corporation · Confocal optical imaging56 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.
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