MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES HYSTEROFIBERSCOPE

Model Number	HYF-XP
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The olympus scope was sent to an independent laboratory for culture testing.All channels were sampled.The device was sampled on 12/21/2021 and over 100 colony forming units (cfus) of unspecified gram positive bacteria was identified.The device was reprocessed and a new sampling occurred on 12/30/2021 and less than one (1) cfus of unspecified microorganisms were detected.The obtained results are in conformance with the requirements.Additional information was provided regarding the cleaning, disinfection and sterilization (cds) processes at the facility.During pre-cleaning, the customer suctioned water from the channels and flushed the air/water and auxiliary washing channel.The customer uses detergent salvanios ph10 for both pre-cleaning and manual cleaning.During manual cleaning, the operating/suction channel and the distal end/area around the elevator are brushed (brush reference clean an1050123).The scope is manually disinfected with deconex.The customer stores the scopes horizontally.Olympus is the customer¿s maintenance company.The scope was not sterilized.The device was returned to olympus for inspection.The insertion tube was deformed and buckling and fibers were broken from the image guide bundle.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported to olympus, the oes hysterofiberscope tested positive for contamination.The issue was found during a routine culture of the scope.All channels were sampled.The sampling occurred during reprocessing, before use.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.
Additional Manufacturer Narrative
The olympus scope was sent to an independent laboratory for culture testing.All channels were sampled.The device was sampled on 12/21/2021 and over 100 colony forming units (cfus) of unspecified gram positive bacteria was identified.The device was reprocessed and a new sampling occurred on 12/30/2021 and less than one (1) cfus of unspecified microorganisms were detected.The obtained results are in conformance with the requirements.Additional information was provided regarding the cleaning, disinfection and sterilization (cds) processes at the facility.During pre-cleaning, the customer suctioned water from the channels and flushed the air/water and auxiliary washing channel.The customer uses detergent salvanios ph10 for both pre-cleaning and manual cleaning.During manual cleaning, the operating/suction channel and the distal end/area around the elevator are brushed (brush reference clean (b)(4)).The scope is manually disinfected with deconex.The customer stores the scopes horizontally.Olympus is the customer¿s maintenance company.The scope was not sterilized.The device was returned to olympus for inspection.The insertion tube was deformed and buckling and fibers were broken from the image guide bundle.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported to olympus, the oes hysterofiberscope tested positive for contamination.The issue was found during a routine culture of the scope.All channels were sampled.The sampling occurred during reprocessing, before use.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.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device was evaluated where no abnormalities were found that could have led to the positive culture.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.Growth of microorganisms were found through culture testing by the user after reprocessing.However, when olympus culture tested after reprocessing in accordance with instructions for use (ifu) before repair, the results conformed to the regulation's recommendation.The following is included in the device ifu: "warning: an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them." olympus will continue to monitor field performance for this device.

• Brand Name: OES HYSTEROFIBERSCOPE
• Common Device Name: HYSTEROFIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13237238
• Report Number: 8010047-2022-01319
• Device Sequence Number: 4709433
• Product Code: HIH
• UDI-Device Identifier: 04953170411571
• UDI-Public: 04953170411571
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2022

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?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2021
• Supplement Date Received by Manufacturer: 03/14/2022
• Initial Report FDA Received Date: 01/12/2022
• Supplement Report FDA Received Date: 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2020
• 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