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

Model Number CYF-5A

Device Problem Break (1069)

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

Event Date 08/23/2023

Event Type  malfunction  

Event Description

The customer reported to olympus that the oes cystonephrofiberscope the bending section cover rubber (curved rubber) was damaged after reprocessing.The issue was observed during reprocessing.No patient or procedure was involved.

Manufacturer Narrative

The device was returned to olympus for a device evaluation and the customer¿s allegation was confirmed.The device evaluation found the following: the insertion part had scratches, the grip had scratches, the eyepiece had scratches, the up/down plate had scratches, the lock engagement lever had scratches, the angulation stopper lever had scratches, the fixed ring had a scratch, the image guide had a scratch, the operation part had corrosion, the operation part had a fluid leak, the up/down plate had a fluid leak, the image had a stain, shaky when connecting light source, and the battery indicator disappeared.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Section g2 was corrected with information that was inadvertently omitted from the event.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 definitive root cause of the damaged curved rubber could not be determined.Stress may have led to the rupture.The instruction manual identifies verbiage which may have prevented the phenomenon in ¿operating instructions _oes bladder renal pelvic fiberscope cyf-5a: chapter 6: application and conditions of cleaning, disinfection, and sterilization: 6.5: conditions for ethylene oxide gas sterilization¿.Olympus will continue to monitor field performance for this device.

• Brand Name: OES CYSTONEPHROFIBERSCOPE
• Type of Device: CYSTONEPHROFIBERSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17754512
• MDR Text Key: 323478062
• Report Number: 3002808148-2023-09875
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339424
• UDI-Public: 04953170339424
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/26/2023

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-5A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/24/2023
• Initial Date FDA Received: 09/15/2023
• Supplement Dates Manufacturer Received: 09/21/2023
• Supplement Dates FDA Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2019
• 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