MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. URETERO-RENO FIBERSCOPE

Model Number URF-P6

Device Problems Display or Visual Feedback Problem (1184); Poor Quality Image (1408)

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

Event Date 09/14/2022

Event Type  malfunction  

Event Description

It was reported the customer scope was blurry, unable to complete procedure as they had no other scope to swap out to.The issue occurred during a therapeutic urology procedure (mid-procedure).Procedure was cancelled and was rescheduled.There was no patient harm or adverse event reported due to the event.No user injury reported.

Manufacturer Narrative

The subject device was received and evaluated.Device evaluation has confirmed the customer reported issue of "blurry image".Device inspection and testing found an excessive broken fibers, device field of view confirmed to be blurry.Fiber image focus and alignment test failed (out of focus).Fiber condition test failed (excessive broken fibers evident).Investigation is ongoing.This report will be supplemented accordingly following investigation.

Manufacturer Narrative

This report is being supplemented to correct information provided in the initial report, and to provide additional information based on the legal manufacturer's final investigation.The date received by manufacturer was sept.15, 2022.The date returned to manufacturer was sept.21, 2022.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.Based on the results of the investigation, the broken fibers caused the blurry image.The root cause of the broken fibers was not able to be determined.It was determined the user could have completed the procedure if they had prepared a spare device, as per the device's instructions for use (ifu): "spare equipment - be sure to prepare another endoscope to avoid interruption of the examination due to equipment failure or malfunction.¿ the suggested event can be detected by handling the device in accordance with the information provided in the device's ifu under "inspection of the endoscopic system." olympus will continue to monitor field performance for this device.

• Brand Name: URETERO-RENO FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15575413
• MDR Text Key: 306985400
• Report Number: 9610595-2022-02747
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340802
• UDI-Public: 04953170340802
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K172298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/05/2022

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: URF-P6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/11/2022
• Initial Date FDA Received: 10/11/2022
• Supplement Dates Manufacturer Received: 11/15/2022
• Supplement Dates FDA Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2018
• 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