MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH LIGHT SOURCE "ENDOLED", FOR FLEXIBLE ENDOSCOPES; ENDOSCOPIC LIGHT SOURCE, BATTERY-POWERED

Model Number	WA91502A
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the subject device's light was not stable.The issue occurred during maintenance.There were no reports of patient involvement.
Additional Manufacturer Narrative
The device was not returned to olympus for inspection and the reported failure was not confirmed.Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: LIGHT SOURCE "ENDOLED", FOR FLEXIBLE ENDOSCOPES
• Common Device Name: ENDOSCOPIC LIGHT SOURCE, BATTERY-POWERED
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 22545583
• Report Number: 9610773-2025-04590
• Device Sequence Number: 17946498
• Product Code: NTN
• UDI-Device Identifier: 04042761073592
• UDI-Public: 04042761073592
• Combination Product (Y/N): N
• PMA/510(K) Number: K133311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: WA91502A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown