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

Model Number	HYF-XP
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information based on the legal manufacturer's final investigation.The device was returned to olympus for inspection, and the reportable malfunction was confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It was confirmed that the device was shipped in accordance with the specifications.The presumed cause and the root cause could not be determined.The events can be detected and prevented in accordance with the following sections of the instructions for use (ifu): oes hysterofiberscope olympus hyf type xp.For safe use handling and general precautions do not coil the insertion tube and universal cord small (diameter of less than 12cm).Equipment damage can result.Do not apply shock to the distal end of the insertion section, particularly lens surface.Visual abnormalities may result.Do not twist or bend the bending section with your hands.Equipment damage may result.Do not squeeze the bending section forcefully.The covering of the bending section may stretch or break and cause water leaks.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the hysterofiberscope, it was difficult to attach the cap to the sterilization nozzle.There were no reports of patient harm.

• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19459668
• Report Number: 3002808148-2024-05030
• Device Sequence Number: 6812791
• Product Code: HIH
• UDI-Device Identifier: 04953170411571
• UDI-Public: 04953170411571
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K891451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2024

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: HYF-XP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2012
• 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