L10 0220220300Recalls & reported problems
Stryker Corporation · LED Light Source with AIM Technology · Class 2
Quick summary
This Stryker LED light source used for confocal optical imaging during surgery. Most of the 76 reports describe the light staying on or getting too hot — burning through surgical drapes and causing thermal burns — plus loss of light output that sometimes cancelled procedures, and electronics or sensor problems. There were 8 injuries and no deaths, and no recalls name this device. Reports in the last 12 months dropped to none from 7 in the prior12 months.
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
- 77
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 07613327051377), received between Oct 15, 2018 and Jun 12, 2026 — classified as 8 injuries, 69 malfunctions.
The most frequently reported specific device problem is “Output Problem” (32 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.
Reports received per month
Most reported problems
Device problems
- Output Problem32
- Temperature Problem18
- Adverse Event Without Identified Device or Use Problem10
- Device Sensing Problem8
- Electrical /Electronic Property Problem8
- Overheating of Device6
- Thermal Decomposition of Device6
- Insufficient Device Problem Information4
Patient problems
- No Clinical Signs, Symptoms or Conditions51
- Insufficient Information20
- No Known Impact Or Consequence To Patient20
- Burn(s)5
- Burn, Thermal5
- No Patient Involvement2
- Superficial (First Degree) Burn2
Recent adverse event reports
The 25 most recent of 77 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 12, 2026Overheating of Device; Device Sensing Problem
IT WAS REPORTED THAT TEST ALL ITEMS (L10 LIGHT SOURCE (REF 220-220-300/SN (B)(6)), SAFELIGHT LIGHT CABLE, AND SAFELIGHT ADAPTER) CONNECTED TO THE EVENT IMMEDIATELY UPON AVAILABILITY OF THE ROOM, CONFIRMING THAT THE ACTION CONTINUES TO OCCUR ON THIS DEVICE ONLY. THE LIGHT CABLE AND ADAPTER FUNCTIONED AS INTENDED WITH A SEPARATE DEVICE. ADDITIONALLY, WE TESTED A SEPARATE LIGHT CABLE AND ADAPTER WITH THE DEVICE IN QUESTION, WHICH AGAIN RESULTED IN A FAILED TRIGGERING OF THE SAFELIGHT SAFETY FUNCTION. THIS ONLY HAPPENED IN ONE PROCEDURE. NOT AWARE ABOUT ISSUE WITH THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25487289 ↗MalfunctionAug 8, 2025Overheating of Device; Output Problem; Overheating of Device; Output Problem
IT WAS REPORTED THAT THE LIGHT CABLE BURNED THE DRAPE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22754798 ↗MalfunctionJul 16, 2025Display or Visual Feedback Problem; Overheating of Device; Device Sensing Problem; Display or Visual Feedback Problem; Overheating of Device; Device Sensing Problem
IT WAS REPORTED THAT LIGHT SOURCE THAT WOULD NOT IMMEDIATELY TURN OFF WHEN PRESSING THE CONSOLE TOUCH SCREEN. THEREFORE, THERE WAS A THERMAL EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22524450 ↗MalfunctionMay 21, 2025Overheating of Device; Output Problem; Temperature Problem; Overheating of Device; Output Problem; Temperature Problem
IT WAS REPORTED THAT WHEN DISCONNECTING LIGHT CORD FROM SAFELIGHT ADAPTER THE LIGHT STAYED ON AND DID NOT TURN OFF. THEREFORE, THERE WAS A THERMAL EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22066144 ↗MalfunctionApr 16, 2025Temperature Problem; Temperature Problem
IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.
Patient problems: Insufficient Information
MAUDE report 21852454 ↗MalfunctionApr 11, 2025Output Problem; Output Problem
IT WAS REPORTED THAT THE LIGHT BOX WENT DOWN AND THAT THERE WAS A FULL LOSS OF LIGHT. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY AND WAS CANCELLED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21826187 ↗MalfunctionApr 9, 2025Computer Software Problem; Output Problem; Computer Software Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21809428 ↗MalfunctionApr 9, 2025Material Frayed; Output Problem; Material Frayed; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21809409 ↗MalfunctionMay 23, 2024Temperature Problem; Temperature Problem
IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19383633 ↗MalfunctionMay 23, 2024Temperature Problem; Temperature Problem
IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19383620 ↗MalfunctionMay 23, 2024Temperature Problem; Temperature Problem
IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19383613 ↗MalfunctionApr 25, 2024Mechanical Problem; Output Problem; Mechanical Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19186360 ↗MalfunctionFeb 26, 2024Device Sensing Problem; Output Problem; Device Sensing Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18778783 ↗MalfunctionFeb 2, 2024Circuit Failure; Output Problem; Circuit Failure; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18632637 ↗MalfunctionJan 17, 2024Device Sensing Problem; Temperature Problem; Device Sensing Problem; Temperature Problem
IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18530808 ↗MalfunctionNov 28, 2023Device Sensing Problem; Output Problem; Device Sensing Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18220830 ↗MalfunctionNov 28, 2023Device Sensing Problem; Output Problem; Device Sensing Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18220803 ↗MalfunctionNov 21, 2023Sensing Intermittently; Output Problem; Sensing Intermittently; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18187547 ↗MalfunctionOct 20, 2023Device Sensing Problem; Optical Problem; Device Sensing Problem; Optical Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17978524 ↗MalfunctionJun 1, 2023Device Sensing Problem; Output Problem; Device Sensing Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17039863 ↗MalfunctionMay 18, 2023Energy Output Problem; Output Problem; Energy Output Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16953272 ↗MalfunctionMay 4, 2023Energy Output Problem; Output Problem; Energy Output Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16867367 ↗MalfunctionFeb 23, 2023Temperature Problem
IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16427900 ↗MalfunctionFeb 16, 2023Thermal Decomposition of Device; Device Emits Odor; Device Emits Odor
IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16391656 ↗MalfunctionOct 31, 2022Output Problem; Temperature Problem; Output Problem
IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15700950 ↗
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
- AIM SafeLight 0233050300Stryker Corporation · Confocal optical imaging62 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.