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 Type  malfunction  

Event Description

The device was returned by the customer for evaluation and repair of issues of spontaneous photographs being taken and colorless water leak.There is no reported harm to any patient or persons.Upon evaluation of the returned device, it was observed that the angulation becomes locked and cannot disengage.This is attributed to the deterioration of angulation mechanism due to rust.This medwatch is being submitted for the reportable issue of angulation becoming locked and not being able to disengage, as observed during device evaluation.

Manufacturer Narrative

The device is returned and an evaluation completed for it.Upon inspection and testing, it was observed that the angulation becomes locked and cannot disengage.This is attributed to the deterioration of angulation mechanism due to rust.Other observations for the device are: forceps channel has pinhole; light guide (lg) coil has air leak and is crushed; distal end rubber coating (a-rubber) adhesive has crack; lg corrugated tube has scratches; treatment tool and brush are caught in the channel; up/down plate, lg bundle, lg coil submerged, and main operation unit are submerged; and there is image cloudiness.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.

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, the root cause of the reported event is unable to be determined.However, the cause of the event is likely due to the angulation lock occurred due to application of irregular load such as strong twisting operation to the right and left while the angulation of the bending section is engaged or abrupt angulation operation.The event can be prevented by following the instructions for use (ifu) which state: ¿operation manual ¿ precautions¿.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 Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15562355
• MDR Text Key: 306433113
• Report Number: 9610595-2022-02708
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170403385
• UDI-Public: 04953170403385
• 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: 11/30/2022

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-V3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/14/2022
• Initial Date FDA Received: 10/07/2022
• Supplement Dates Manufacturer Received: 11/02/2022
• Supplement Dates FDA Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2019
• 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