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

Model Number URF-V2

Device Problem Scratched Material (3020)

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

Event Type  malfunction  

Manufacturer Narrative

E1- (b)(6) medical center.The device was returned and evaluated, and the customer¿s allegation was confirmed.Additional evaluation findings are as follows: due to a chip on the distal end, water tightness was lost; due to a pinhole on the bending section cover, water tightness was lost; due to the wear of the angle wire, the bending angle in the up direction did not meet the standard value; the control unit, switch box, scope cover, grip, angulation lever, insertion tube rotation ring, universal cord, video cable, light guide cover glass, light guide connector, video connector, video connector case all had a scratch.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

The customer reported that the videoscope had leakage near the tip.There were no reports of patient harm.During the device evaluation, the following reportable malfunction was found: the forceps channel port was shaved.This medical device report (mdr) is being submitted to capture the reportable malfunction found during the evaluation.

Manufacturer Narrative

This report is being supplemented to correct information that was provided in the initial medwatch report and 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.The device met all specifications at the time of shipment.It has been over 5 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, it is likely the event was caused by stress of repeated use, external factors, or handling of the device however, a conclusive root cause could not be determined.Instructions, operation manual for urf-v2 chapter 3 ¿preparation and inspection¿ section 3.3 ¿inspection of the endoscope¿ describes how to inspect for the subject event as below.¿inspection of the endoscope 1.Inspect the control section, video connector, and light guide connector for excessive scratching, deformation, loose parts, or other irregularities.¿ 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: 18325228
• MDR Text Key: 330487809
• Report Number: 9610595-2023-19552
• 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: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2024

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: Health Professional
• Device Model Number: URF-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2023
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2018
• 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