MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. FIBERSCOPE "CYF-4A", WITH SUCTION; CYSTONEPHROFIBERSCOPE

Model Number A20801A

Device Problem Microbial Contamination of Device (2303)

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

Event Date 10/19/2023

Event Type  malfunction  

Event Description

The customer reported to olympus that during routine microbiological testing, the fiberscope with suction tested positive for an unexpected contamination.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

The olympus scope was sent to an independent laboratory for culture testing and results are still pending.The investigation is ongoing and follow up with the customer is currently being performed.After culture testing, the device will be evaluated.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

Correction to h10 of the initial report.Since the subject device model was discontinued, the device was returned without culture test or repair by olympus.This report is being supplemented to provide additional information based on results of third party testing and the legal manufacturer's final investigation.Despite good faith attempts the user cleaning disinfection and sterilization (cds) processes were not shared.The user provided the following result of the culture test, performed at the third-party labs: sampling date: oct 19, 2023.Sampling from: all channels.Cfu: 1cfu.Bacterial identification: micrococcus lylae.The device history record (dhr) was unable to be reviewed for this device as it was manufactured over 15 years ago however, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The reported event was not confirmed as the scope was not microbiologically tested by olympus.Based on the results of the investigation, a root cause could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: FIBERSCOPE "CYF-4A", WITH SUCTION
• Type of Device: CYSTONEPHROFIBERSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18278947
• MDR Text Key: 330249570
• Report Number: 9610595-2023-18943
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 01/18/2024

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
• Device Operator: Health Professional
• Device Model Number: A20801A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 01/18/2024
• Supplement Dates FDA Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: No
• 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