MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. OES CYSTONEPHROFIBERSCOPE; FLEXIBLE FIBREOPTIC CYSTONEPHROSCOPE

Model Number CYF-5

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 10/24/2022

Event Type  malfunction  

Event Description

It was reported "the irrigation port falls right out".The issue was found during reprocessing.There is no patient involvement on this reported event.No user injury reported.

Manufacturer Narrative

The subject device was received and evaluated.Device evaluation has confirmed the customer reported issue.Device evaluation noted the biopsy port missing upon received.The scope has fluid in the eyepiece causing the image to be unseen.The cover glass cracked and was found loose.The eyepiece body has corrosion with fluid inside.The stain in channel (distal end plastic c- body) which cannot be removed was noted.Due to the port missing, the insulation test was not able to be performed.The investigation is ongoing.This report will be supplemented accordingly following the investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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 could not be determined.It is unknown whether the instrument channel port falling off was due to stress, handling, or other factors.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is (b)(4).

• Brand Name: OES CYSTONEPHROFIBERSCOPE
• Type of Device: FLEXIBLE FIBREOPTIC CYSTONEPHROSCOPE
• 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15821696
• MDR Text Key: 304203686
• Report Number: 8010047-2022-12142
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339417
• UDI-Public: 04953170339417
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2024

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: 10/28/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/24/2022
• Initial Date FDA Received: 11/17/2022
• Supplement Dates Manufacturer Received: 11/30/2022; 05/03/2024
• Supplement Dates FDA Received: 12/17/2022; 05/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2022
• 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