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

Model Number HYF-1T

Device Problem Failure to Clean Adequately (4048)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was observed that during the device evaluation, the hysterofiberscopes light guide cover glass had a foreign body.There were no reports of patient involvement.

Manufacturer Narrative

The device was returned and evaluated.In addition to the malfunction documented in b5, the additional evaluation findings are as follows: the light guide (lg) rod and control unit both have a burr, the lg connector, universal cord, grip, diopter ring, and the eye piece all have a scratch, the grip, control unit, and lg lens all have discoloration, control unit has a crack, due to wear of angle wire; the bending angle in the up direction does not meet the standard value, and the image guide bundle has significant breakages.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided.

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.Based on the results of the investigation, the foreign material could not be identified nor the root cause of it.Per additional follow up from the customer, the device was cleaned, disinfected, and sterilized the product before it sent in for repair.According to the customer, it is not known when the foreign material adhered to the nozzle.The event can be detected/prevented in accordance with the following instructions for use: chapter 7 care and storage: 7.1 application of the method of cleaning and disinfection to each product.7.2 condition of cleaning and disinfection.7.3 request about cleaning and disinfection.7.4 cleaning and disinfection.Olympus will continue to monitor field performance for this device.

• Brand Name: OES HYSTEROFIBERSCOPE
• Type of Device: 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: 18643628
• MDR Text Key: 335823093
• Report Number: 3002808148-2024-01099
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K891451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HYF-1T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2024
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1