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

Model Number HYF-XP

Device Problem Microbial Contamination of Device (2303)

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

Event Type  malfunction  

Manufacturer Narrative

The suspect device has not yet been returned to olympus for evaluation and the investigation is ongoing.The physical device evaluation has not been completed.Prior to the device evaluation, the device was sent out for additional microbiological testing.The customer provided the cleaning, disinfection, and sterilization process stating that the scope was stored in a simple drying cabinet.The scope was not sterilized.No other information was provided in the document.The cleaning, disinfection, and sterilization (cds) was performed by the customer.There was no patient infection.The hygiene microbiological investigation report indicated the channels of the scope were cultured and found 1 cfu of bacillus spp.Mesophiles.The results obtained comply with the target level for an endoscope subjected to high level disinfection and rinsed with sterile water.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

The customer reported to olympus, the oes hysterofiberscope tested positive for an unexpected contamination.The issue was found during a routine culture of the scope.The user did not report any contamination or any other serious deterioration in state of health of any person, to which the scope could have been a contributory cause.

Manufacturer Narrative

Correction to b5, the customer culture results were inadvertently left out of the initial report.Please see b5 for further information.Correction to h10, please see h10 for further information.This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.The device was evaluated where no abnormalities were found that could have led to the positive culture.Defects were noted where the following were noted: - curved rubber to leak.- curved pipe deformation.- image guide bundle missing.However, these defects alone are not considered severe enough to cause a potential adverse event.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, a root cause could not be determined.The hygiene microbiological investigation report provided by olympus indicated the channels of the scope were cultured and found 1 cfu of bacillus spp.Mesophiles.The results obtained did not comply with the target level for an endoscope subjected to high level disinfection and rinsed with sterile water.The subject device was reprocessed according to the instructions in the instructions for use (ifu) and re-culture tested where the results were <1 cfu and did comply with the target level for an endoscope subjected to high level disinfection and rinsed with sterile water.The instruction manual of hyf-xp describes the reprocessing methods in the following chapters: chapter "compatible reprocessing methods and chemical agents".Chapter "cleaning, disinfection, and sterilization procedures".Olympus will continue to monitor field performance for this device.

Event Description

The user did not share their non-conforming culture results however, the subject device was reprocessed and re-culture tested on 06april2022 by the user facility where the results were <1 cfu in all channels and conformed to the regulation's recommendation.

• 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: 16185380
• MDR Text Key: 309131004
• Report Number: 3002808148-2023-00489
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04953170411571
• UDI-Public: 04953170411571
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K891451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HYF-XP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2021
• 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