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

Model Number URF-P7

Device Problem Scratched Material (3020)

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

Event Type  malfunction  

Manufacturer Narrative

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.It has been over 4 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, it is it is likely the instrument channel port was scraped due to stress applied during use, external factors, or handling of the device.However, a definitive root cause could not be determined.The reported issue (leakage) was confirmed and found to be caused due to external factors.It was observed the tip cover was crushed which caused a leakage.In addition, service found the insertion tube, the control section, the eyepiece, the grip, the angle lever, and the up/down angulation lock were scratched due to external factors.Per the legal manufacturer, there is no potential for these issues to cause or contribute to death or serious injury if the malfunctions were to recur.Olympus will continue to monitor field performance for this device.

Event Description

The customer reported the subject device exhibited a leakage.There was no patient or user injury reported due to the event.The subject device was returned to an olympus service center for evaluation.Upon inspection and testing of the returned device, it was observed the instrument channel port was scraped.This report is being submitted for the malfunction found during evaluation of the device (instrument channel port scraped).

• 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: 15171996
• MDR Text Key: 304896398
• Report Number: 9610595-2022-00645
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170403811
• UDI-Public: 04953170403811
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K181451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-P7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2018
• 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