MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH RHINO-LARYNGOFIBERSCOPE

Model Number	ENF-GP
Medical Device Problem Codes	Device Reprocessing Problem (1091); Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was observed that during the device evaluation, the rhino-laryngofiberscope image guide cover lens was dirty.There was no patient involvement.
Additional Manufacturer Narrative
The device was returned to olympus for inspection where a residue foreign material was confirmed.Based on the results of the investigation, olympus confirmed foreign material came out of the device, but the type of the material or root cause cannot be identified.A definitive root cause cannot 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: RHINO-LARYNGOFIBERSCOPE
• Common Device Name: RHINO-LARYNGOFIBERSCOPE
• 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: 24865607
• Report Number: 9610773-2026-02964
• Device Sequence Number: 13071276
• Product Code: EOB
• UDI-Device Identifier: 04953170078231
• UDI-Public: 04953170078231
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K011869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/13/2026

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: Other
• Device Model Number: ENF-GP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 04/13/2026
• 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