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 12/22/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned and customer allegation was confirmed.The forceps channel port was detached.There were few additional findings.The adhesive on bending section cover was chipped.Due to wear of angle wire, bending angle in upward direction does not meet the standard value.Control unit was dirty due to water leakage.The control section, grip and eyepiece was sticky.A foggy image occurred in the view field of eyepiece.Due to damage on image guide bundle, the image had a stain.Venting connector under grip was corroded.Scratches were found throughout the device.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental will be submitted on completion of investigation or if any additional information is available.

Event Description

The company representative on behalf of the customer reported, the forceps channel port was broken.There were no reports of patient harm associated with the event.

Event Description

Additional information received from the customer: there were no effects on patients.The procedure was a "cystoscopy".The procedure was for diagnostic (inspection) purposes and was complete the using the device as is.There was no procedural delay.Pre-use inspection of the device was carried out.

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 forceps stopper cap was found to have come off.The root issue could not be determined, however, it is possible that the detachment of the forceps hole was caused by stress or handling.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: 16218392
• MDR Text Key: 308648362
• Report Number: 3002808148-2023-00639
• 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,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2023

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: 12/26/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/26/2022
• Initial Date FDA Received: 01/20/2023
• Supplement Dates Manufacturer Received: 02/02/2023
• Supplement Dates FDA Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2013
• 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