MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. OES HYSTEROFIBERSCOPE

Model Number	HYF-XP
Medical Device Problem Codes	Corroded (1131); Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer returned the hysterofiberscope, which is an olympus asset with no reported complaint.During the evaluation of the device, the service repair technician observed corrosion on the distal end and a sticky body control unit.There was no patient involvement.
Additional Manufacturer Narrative
The device was returned to olympus for inspection.A root cause could not be identified.Based on the results of the investigation, regarding the corrosion on the distal end, it is likely degradation led to component failure.Regarding the sticky body control unit, a probable 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.

• Brand Name: OES HYSTEROFIBERSCOPE
• Common Device Name: HYSTEROFIBERSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; +1(508)207-7661
• MDR Report Key: 50118732
• Report Number: 3002808148-2026-26658
• Device Sequence Number: 10217027
• Product Code: HIH
• UDI-Device Identifier: 04953170340178
• UDI-Public: 04953170340178
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K891451
• 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): 08/03/2026

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: HYF-XP
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/10/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 08/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown