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

Model Number	HYF-XP
Medical Device Problem Code	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 during the device inspection, that the hysterofiberscope exhibited foreign material in the distal end.There were no reports of patient involvement.
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.New information added to the following fields: h3 and h6.It has been over two (2) years since the subject device was manufactured.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the type of the foreign material or root cause cannot be identified.However, it was presumed that reprocessing deviated from the instruction manual, thus there is a possibility that the foreign object remained, or there is a possibility that due to physical damage on the device, the foreign object could not be removed.The event can be prevented by following the instructions for use which state: "chapter 6 application and condition of cleaning, disinfection, and sterilization.·chapter 7 procedure of cleaning, disinfection, and sterilization.Also, as a result of confirming the contents of the instruction manual, we can confirm the description below.With this, there is a possibility that occurrence of the physical damage on the insertion section can be prevented.¿ while in use, do not pull of the universal cord.Scope connector r will be pulled out from the socket of the light source and the endoscopic image will not be visible.¿ do not coil the insertion tube and the universal cord with a diameter less than 12 cm.Equipment damage can result.¿ do not apply shock to the distal end of the insertion tube, particularly the objective lens surface of the distal end.Visual abnormalities may result.¿ do not twist or bend the bending section.Equipment damage may result.¿ do not squeeze the bending section forcefully.The covering of the bending section may stretch or break causing water leaks." 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20400347
• Report Number: 3002808148-2024-09728
• Device Sequence Number: 6546227
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2024

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: Other
• Device Model Number: HYF-XP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2022
• 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