Olympus WA91502ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Light source "EndoLED", for flexible endoscopes · Class 2
Quick summary
This Olympus EndoLED light source powers flexible endoscopes. The 28 reports mostly describe the unit failing to power up or not staying on, dim or fading light, and corrosion or cleaning problems, with no patient harm noted. No deaths or injuries are reported.
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
- 29
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 04042761073592), received between Apr 26, 2024 and Sep 24, 2026 — classified as 29 malfunctions.
The most frequently reported specific device problem is “Failure to Power Up” (3 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
- Failure to Power Up3
- Activation Failure2
- Complete Loss of Power2
- Failure to Clean Adequately2
- Leak/Splash2
- Mechanical Problem2
- No Device Output2
- Output Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions29
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Charging Problem
The customer reported abnormal lamp lit up during inspection for use involving an Olympus Endoscopic light source, battery powered. There were no reports of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883691 ↗MalfunctionAug 21, 2026Unexpected Shutdown
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50375900 ↗MalfunctionMay 12, 2026Electrical /Electronic Property Problem
IT WAS REPORTED THAT THE BATTERY-POWERED ENDOSCOPIC LIGHT SOURCE DID NOT CLICK INTO THE ON POSITION OR REMAINED ON, AND THE DEVICE DID NOT STAY ON WITHOUT HOLDING THE BUTTON. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25153231 ↗MalfunctionMay 1, 2026Activation Problem
IT WAS REPORTED THE ENDOSCOPIC LIGHT SOURCE EXPERIENCED THAT POWER DID NOT TURN ON EVEN WHEN IT WAS SET DURING SERVICE MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25056559 ↗MalfunctionApr 29, 2026Activation Failure
IT WAS REPORTED THAT THE ENDOSCOPIC LIGHT SOURCE LIGHTS WERE FADING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25035604 ↗MalfunctionApr 27, 2026Poor Quality Image
IT WAS REPORTED THAT THE ENDOSCOPIC LIGHT SOURCE, BATTERY POWERED EXPERIENCED DIM LIGHT DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25001845 ↗MalfunctionApr 23, 2026Complete Loss of Power
IT WAS REPORTED THAT, THE BATTERY POWERED ENDOSCOPIC LIGHT SOURCE DOES NOT STAY ON. THE ISSUE WAS IDENTIFIED WHEN THE DEVICE WAS TAKEN OUTSIDE OF THE BOX. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24971418 ↗MalfunctionMar 30, 2026Poor Visibility
IT WAS REPORTED THAT THE ENDOSCOPIC LIGHT SOURCE, BATTERY-POWERED EXHIBITED DIM LIGHT DURING A CYSTOSCOPY PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24727981 ↗MalfunctionMar 16, 2026Break
NO ADDITIONAL INFORMATION FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24612202 ↗MalfunctionMar 3, 2026Corroded
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24503957 ↗MalfunctionDec 5, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ENDOSCOPIC LIGHT SOURCE EXHIBITED FOREIGN OBJECTS IN SOCKET. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23730318 ↗MalfunctionJul 18, 2025No Device Output; No Device Output
IT WAS REPORTED THAT THE SUBJECT DEVICE'S LIGHT WAS NOT STABLE. THE ISSUE OCCURRED DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22545583 ↗MalfunctionJun 7, 2025Defective Device; Defective Device
IT WAS REPORTED THE SUBJECT DEVICE NO LONGER WORKS. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22162352 ↗MalfunctionJun 2, 2025Connection Problem; Connection Problem
IT WAS REPORTED THE SUBJECT DEVICE PART CONNECTED TO THE SCOPE WAS ROTATION. THE ISSUE WAS FOUND DURING SET UP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22125435 ↗MalfunctionMay 15, 2025Activation Failure; Activation Failure
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD A LIGHT REPEATEDLY TURNED ON AND OFF EVEN AFTER REPLACING THE LIGHT SOURCE. THE ISSUE OCCURRED DURING SETUP. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22029754 ↗MalfunctionMay 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21994050 ↗MalfunctionMay 7, 2025No Device Output; Failure to Power Up; No Device Output; Failure to Power Up
IT WAS REPORTED THAT THE LIGHTSOURCE DID NOT TURN ON CONTINUOUSLY, UNLESS THE BUTTON TO TURN ON THE LIGHT WAS PRESSED AND HELD. THE EVENT OCCURRED DURING INSPECTION FOR USE, PRIOR PATIENT IN ROOM FOR AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21975201 ↗MalfunctionApr 25, 2025Output Problem; Output Problem
IT WAS REPORTED THAT THE SUBJECT DEVICE NOT WORKING. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21909937 ↗MalfunctionApr 24, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE SUBJECT DEVICE EXHIBITED OVERHEATING HANDLE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21903436 ↗MalfunctionMar 19, 2025Defective Component; Defective Component
IT WAS REPORTED THE SUBJECT DEVICE EXPERIENCED A MALFUNCTION DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21647259 ↗MalfunctionFeb 20, 2025Mechanical Problem; Mechanical Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CLIP MECHANISM OF THE SUBJECT DEVICE HAD FAILED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21422565 ↗MalfunctionJan 6, 2025Output Problem; Output Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21084824 ↗MalfunctionNov 26, 2024Failure to Power Up; Failure to Power Up
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20777108 ↗MalfunctionOct 22, 2024Leak/Splash; Mechanical Problem; Leak/Splash; Mechanical Problem
IT WAS REPORTED THE LIGHT SOURCE OF SUBJECT DEVICE DAMAGED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20505615 ↗MalfunctionAug 22, 2024Power Problem; Power Problem
IT WAS REPORTED THE LIGHT SOURCE TURNED ON, BUT DID NOT STAY ON. A BUTTON HAD TO BE HELF FOR THE LIGHT TO STAY ON. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20037626 ↗
Other Led Light Source devices
- VIDEO SYSTEM CENTER CV-170Olympus Medical Systems Corp. · Led Light Source811 reports
- SpyGlass DS M00546650Boston Scientific Corporation · Led light source154 reports
- LUCEA LED® ARDLCA209016AMaquet Sas · Led light source1 recall0 reports
- LUCEA LED® ARDLCA506006AMaquet Sas · Led light source1 recall0 reports
- LUCEA LED® ARDLCA109008AMaquet Sas · Led light source1 recall0 reports
- LUCEA LED® ARDLCA506000AMaquet Sas · Led light source1 recall0 reports
- n.a. TL300Karl Storz GmbH & Co. KG · Led light source11 reports
- VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500Olympus Medical Systems Corp. · Led Light Source9 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.