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

Model Number CYF-5

Device Problem Material Separation (1562)

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

Event Date 01/17/2024

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found the part was not attached between control body assembly and proximal end.The port came away during the bedside clean and it was evident there was fluid staining.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

It was observed that during the device evaluation, the cystonephrofiberscope exhibited the biopsy port came away from the scope when the tap was removed.There were no reports of patient involvement.

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 root cause of the disconnected biopsy port from the scope was it was not attached between control body assembly and proximal port during the bedside cleaning due to stress.The event can be detected/prevented by following the instructions for use which state: ¿instructions: oes cystonephrofiberscope, olympus cyf-5, olympus cyf-5a.Important information ¿ please read before use, [warning]: do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, or control section.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, or light guide cable with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient.¿.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: 18616781
• MDR Text Key: 335078202
• Report Number: 9610595-2024-02136
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170292323
• UDI-Public: 04953170292323
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K221690
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/08/2024

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: 01/22/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/23/2024
• Initial Date FDA Received: 01/31/2024
• Supplement Dates Manufacturer Received: 02/27/2024
• Supplement Dates FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2011
• 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