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

Model Number URF-V2

Device Problems Mechanical Problem (1384); Material Protrusion/Extrusion (2979)

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

Event Date 08/03/2023

Event Type  malfunction  

Manufacturer Narrative

The subject device was received and evaluated.Device evaluation found the device insertion section (a-rubber) was found damaged (has a cut/tear), due to a cut on a-rubber, water tightness is lost.The customer reported issue was confirmed.In addition, as stated in section b5, inspection found metal was observed protruding/sticking out from the bending tube section (sticking out of the broken metal wires from the inside).Furthermore, the following defects were identified during device inspection: the distal end has a burn.Adhesive on a-rubber is detached.Control unit has a scratch.S-cover has a scratch.Video connector has a scratch.Connecting tube has a scratch.Due to wear of angle wire, bending angle in up direction does not meet the standard value.Due to damage, angulation lever does not move smoothly.Due to damage on ch-tube (channel tube), forceps cannot be inserted smoothly.Due to a cut on ccd cable, image noise occurs during angulation in ud direction.Due to a cut on ccd cable, image noise occurs and an image cannot be displayed.Due to damage on circuit board of video plug section, image noise occurs and an image cannot be displayed.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

Customer sent a repair request reported with an issue of "insert rubber tear", found during inspection before use for a therapeutic procedure.The device was replaced and the intended procedure was completed using a similar device.Device return evaluation found both of the device a-rubber (insertion section) and bending tube are damaged (bending section is broken, metal is sticking out).This report is being submitted due to the finding of broken bending section with metal sticking out (metal protrusion) identified during device evaluation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to correct d5 and h4.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 suggested event could not be concluded, although it can be presumed that the defect was caused by stress of repeated use, external factors, or handling of the device.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: 17671688
• MDR Text Key: 322525443
• Report Number: 9610595-2023-12638
• Device Sequence Number: 1
• Product Code: FGB
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/17/2023

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: 08/07/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/17/2023
• Initial Date FDA Received: 09/01/2023
• Supplement Dates Manufacturer Received: 10/13/2023
• Supplement Dates FDA Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2018
• 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