MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-VH

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 08/02/2022

Event Type  malfunction  

Event Description

The customer reported to olympus that during reprocessing of the cysto-nephro videoscope, foreign material (fiber) was found exiting the scope channel.There was no patient involvement, or user injury associated with this event.

Manufacturer Narrative

The customer suspected device was returned for investigation.Upon evaluation of the returned device the following defects were found, bending section rubber cracked, insertion tube scratched, peeling channel wall, minor fading, control body scratched, and video connector dented.The faulty parts were replaced, and the device was returned to the user facility.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

This report is been submitted to provide additional information from the customer.The follow field updated: b5.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The following field was updated: h4, h6 and h10.The subject device was returned to olympus for device evaluation and investigation was unable to confirm the reported issue.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The investigation noted that it has been less than one year since the device was manufactured.The investigation did not establish a definitive root cause for the reported event.However, was no air leak in the device, and there was no detailed description or image of the foreign material.Thus, we could not determine the cause of this phenomenon.The investigation reported that the following was found, fiber (foreign material) came out from the instrument channel, no air leak in the device, and no detailed description or image of the foreign material.As the result of checking the manufacturing history, the subject device was shipped without abnormality in manufacturing.Olympus will continue to monitor field performance for this device.

Event Description

Additional information received from the customer that the event was first noticed in the scope room with borescope and the scope fiber was damaged by end of the lumen.It was reported that the scope was sterilized.

• Brand Name: CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama, odakura; nishigo-mura; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15339617
• MDR Text Key: 305586890
• Report Number: 3002808148-2022-01628
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/22/2022

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-VH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/03/2022
• Initial Date FDA Received: 09/01/2022
• Supplement Dates Manufacturer Received: 08/24/2022
• Supplement Dates FDA Received: 09/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2021
• 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