MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. URETERO-RENO VIDEOSCOPE

Model Number URF-V

Device Problem Unexpected Shutdown (4019)

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

Event Date 11/16/2022

Event Type  malfunction  

Event Description

The customer reported to olympus, the uretero-reno videoscope switched off during an unknown procedure.There were no reports of patient harm associated with the event.

Manufacturer Narrative

The device was returned and customer allegation was confirmed.There was no image or image was unstable due to disconnection/ short-circuit in the image sensor cable.It was assumed that the defect was caused by water invasion of the device through biopsy channel.Additionally, it was noted that the distal end was burned.The universal cord and cable tube unit was scratched.The housing of the scope connector plug unit was damaged.The charge coupled device (ccd) unit had horizontal lines.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental will be submitted in completion of investigation or if any additional information is available.

Manufacturer Narrative

This report is being submitted for additional information provided by the customer.The investigation is ongoing.A supplemental will be submitted in completion of investigation or if any additional information is available.

Event Description

It was further reported, the event occurred during a retrograde intrarenal surgery (rirs).The malfunction occurred about 20 minutes after use.The procedure was interrupted; however, was completed with a similar device.The device was not inspected before use.

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.It has been over 7 years since the subject device was manufactured.Based on the results of the investigation, an air leak occurred in the forceps channel and it¿s likely the charge coupled device (ccd) unit failed due to moisture that entered inside, which led to the event that the device was turned off.However, a final root cause of this event was unable to be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• 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: 15973404
• MDR Text Key: 308537833
• Report Number: 3002808148-2022-05186
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340321
• UDI-Public: 04953170340321
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2023

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: URF-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/16/2022
• Initial Date FDA Received: 12/13/2022
• Supplement Dates Manufacturer Received: 12/19/2022; 01/06/2023
• Supplement Dates FDA Received: 01/02/2023; 01/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2015
• 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