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

Model Number	HYF-XP
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device has been returned to olympus for evaluation.In addition to the reportable malfunction mentioned in b5, it was observed, due to a pinhole on channel tube, water tightness was lost, stress was noted caused by excessive squeezing, connecting tube had a dent, connecting tube had a scratch, the coating of the connecting tube was peeling, due to wear of angle wire, bending angle in up direction did not meet the standard value, the light guide (lg) bundle had breakage, the image guide (ig) protector had a cut, the universal cord had a scratch, the angulation lever had a scratch, the lock engagement (fe) lever had a scratch, the control unit has a burr, the control unit had a crack, the grip had a scratch, the diopter ring had a scratch, the eyepiece had a scratch, and the angle wire became longer than normal.The investigation is ongoing, and a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
The customer reported to olympus, the oes hysterofiberscope had abnormal image.Upon inspection of the customer¿s returned device it was observed, the forceps plug cap was scrapping off.This report is being submitted for the malfunction found during evaluation.There was no harm or user injury reported due to the event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 14 years since the subject device was manufactured.Based on the results of the investigation, it was confirmed that the forceps plug mouthpiece had been scraped however, a definitive root cause could not be determined.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: 16435693
• Report Number: 3002808148-2023-01712
• Device Sequence Number: 3151074
• Product Code: HIH
• UDI-Device Identifier: 04953170340178
• UDI-Public: 04953170340178
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2023

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: 01/29/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2023
• Supplement Date Received by Manufacturer: 07/04/2023
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2008
• 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