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

Model Number CYF-5

Device Problem Microbial Contamination of Device (2303)

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

Event Date 09/19/2021

Event Type  malfunction  

Manufacturer Narrative

The customer¿s contact, occupation and health profession are unknown at this time.The returned device is pending evaluation.An investigation is ongoing to obtain additional information regarding the reported event.If additional information is received this report will be supplemented accordingly.

Event Description

Olympus (b)(4) was informed by the user facility that after a microbiological routine control on this oes cystonephrofiberscope, the user facility detected an unexpected contamination.The user did not report any contamination or any other serious deterioration in state of health of any person, to which this medical device could have been a contributory cause.The scope has been returned to the regional repair center.

Manufacturer Narrative

Correction to b3, the event date was (b)(6) 2021.Correction to d9, the date of return was 05oct2021.Correction to g2 to add the foreign country france.This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.After the device was returned to olympus, it was sent out for additional testing.The microbiological analysis report indicated the channels of the scope were cultured and results obtained showed no contamination.The device was evaluated and no defects of the device were found.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been 8 years since the subject device was manufactured.Based on the results of the investigation, it is unlikely the positive culture was caused by the device.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, growth of microorganisms could not be confirmed.The following is included in the instructions for use (ifu): "reprocessing manual: 1.4 precautions: 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 CYSTONEPHROFIBERSCOPE
• Type of Device: CYSTONEPHROFIBERSCOPE
• 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: 12675200
• MDR Text Key: 281657719
• Report Number: 8010047-2021-13516
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339417
• UDI-Public: 04953170339417
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K032092
• 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: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2013
• 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