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

Model Number URF-V3

Device Problem Mechanical Jam (2983)

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

Event Date 12/04/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the evaluation found the following: due to discoloration of light guide bundle, illumination is uneven; due to damage on charging coupled device (ccd) unit, error e311 (white balance incomplete) occurs; due to corrosion on the angle mechanism, bending section cannot be controlled at all; due to a pinhole on channel tube, water tightness is lost; due to a dent on distal end, water tightness is lost; distal end has discoloration; bending section cover or distal sheath rubber has a scratch; bending section cover or distal sheath rubber has a chip; up/down angulation lever plate is sticky; universal cord is sticky; universal cord has a scratch; due to a dent on channel tube, forceps cannot be inserted smoothly; light guide bundle is slipping down; due to breakage of light guide bundle, illumination is poor; due to dirt on light guide bundle, illumination is uneven; due to damage, switch4 does not work; due to slipping down of light guide bundle, the narrow band imaging (nbi) observation image is not bright enough; and control unit is sticky due to water leakage.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus, the uretero-reno videoscope, white balance cannot be maintained and the center of the screen is yellowish.The issue was found during an unknown event.The procedure was unknown.There were no reports of patient harm.The device was returned to olympus and the evaluation found that the angle was locked.This report is being submitted to capture the reportable malfunction found during evaluation.

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.Based on the results of the investigation, a definitive root cause of the reported angulation locked and cannot be disengaged issue could not be determined, however, the issue was likely the result of corrosion/rust on the angle mechanism due to user handling/mishandling and or external factors.The event may be detected/prevented by following the instructions for use which state: instructions, operation manual chapter 4 ¿operation,¿ section 4.2 ¿insertion¿.Angulation of the distal end if the angulation control mechanism or any other part of the system is not functioning properly, stop the examination immediately and place the up/down angulation lock in the free ¿f¿ position.Then carefully withdraw the endoscope while observing the endoscopic image.If the endoscope cannot be withdrawn from the patient smoothly, do not attempt to forcibly withdraw it.Rather, withdraw the endoscope carefully.If the endoscope cannot be withdrawn from the patient, consider removing it through open surgery and take proper measures.Forcibly withdrawing the endoscope may cause patient injury, bleeding, and/or perforation.If any irregularity with the endoscope is observed, contact olympus.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: 18484507
• MDR Text Key: 332560110
• Report Number: 9610595-2024-00604
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170435119
• UDI-Public: 04953170435119
• 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,Followup
• Report Date: 02/02/2024

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-V3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/15/2023
• Initial Date FDA Received: 01/10/2024
• Supplement Dates Manufacturer Received: 01/24/2024
• Supplement Dates FDA Received: 02/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2020
• 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