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

Model Number URF-V2

Device Problem Peeled/Delaminated (1454)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned and the evaluation found that the coating of the image guide pipe was peeling.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was observed during the device inspection, that the videoscope exhibited the coating of the image guide pipe peeling off.There were no reports of patient involvement.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Corrected fields: g2 (foreign must be selected).Additional information added to fields h3 and h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 6 years since the subject device was manufactured.Based on the results of the investigation, it is likely the event was caused by stress of repeated use, external factors, or handling.The event can be detected/prevented by following the instructions for use: inspection method for the suggested event is described in the operation manual ¿chapter 3 preparation and inspection 3.3 inspection of the endoscope".Olympus will continue to monitor field performance for this device.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19067062
• MDR Text Key: 339785543
• Report Number: 9610595-2024-07321
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170343582
• UDI-Public: 04953170343582
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

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: Other
• Device Model Number: URF-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 04/18/2024
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2018
• 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