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	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1, initial reporter establishment name: (b)(6).The device was returned to olympus for inspection and the reported failure was not confirmed.Based on the results of the investigation a root cause could not be identified.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported that the endoscopic light source, battery powered experienced dim light during inspection for use.There were no reports of patient involvement.

• 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 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 25001845
• Report Number: 9610773-2026-03302
• Device Sequence Number: 8729436
• Product Code: NTN
• UDI-Device Identifier: 04042761073592
• UDI-Public: 04042761073592
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/27/2026

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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