MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. OES CYSTONEPHROFIBERSCOPE

Model Number CYF-5

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 been returned to olympus for evaluation and the investigation is ongoing.The physical device evaluation has been completed.Prior to the device evaluation, the device was sent out for additional microbiological testing.The hygiene microbiological investigation report indicated the channels of the scope were cultured and did not detect microbiological growth.The results obtained comply with the target level for an endoscope subjected to high level disinfection and rinsed with sterile water.The device evaluation found the following non-reportable malfunctions: the bending section cover adhesive was damaged; the connecting tube had coating peeling off; the image guide bundle had fiber breakage.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus, the oes cystonephrofiberscope tested positive for an unexpected contamination.The issue was found during a routine culture of the scope at maintenance.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

This report is being supplemented to provide additional information based on correction to h7, h9.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation and correction to h4.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 contamination could not be confirmed.Olympus will continue to monitor field performance for this device.

• Brand Name: OES CYSTONEPHROFIBERSCOPE
• 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: 18136159
• MDR Text Key: 329564558
• Report Number: 9610595-2023-17197
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339417
• UDI-Public: 04953170339417
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K221690
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Remedial Action: Relabeling
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2024

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: CYF-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 11/14/2023
• Supplement Dates Manufacturer Received: 02/21/2024; 02/21/2024
• Supplement Dates FDA Received: 02/21/2024; 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0684-2024
• Patient Sequence Number: 1