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

Model Number URF-V3

Device Problem Failure to Clean Adequately (4048)

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

Event Type  malfunction  

Manufacturer Narrative

During inspection and testing, service found debris at a void in the adhesive on the bending section cover due to insufficient reprocessing.A review of the device history record found no deviations that could have caused or contributed to the reported event.The device shipped according to specifications.Based on the results of the legal manufacturer's investigation, it is likely the foreign material was attached to the device due to the adhesive cracking from user handling.The insertion section (metal part) around the crack was corroded and rust was generated.The rust was then specified as debris.However, a definitive root cause of the reported issue could not be identified.The device's instruction manual provides the following instruction, which may help to prevent the issue: ¿inspect the external surface of the entire insertion section, including the bending section and the distal end for dents, bulges, swelling, scratches, peeling of coating, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities.¿ olympus will continue to monitor field performance for this device.The report of a leak was confirmed during testing.The channel leaked due to being scraped by repeated insertion and withdrawal of brushes and accessories.The report of marks on the distal end were not confirmed.There was corrosion and rust on the distal end of the device and the lens but no melting or black marks were observed.In addition, the adhesive on the bending section cover was cracked and peeling, the bending section cover was damaged and metal was exposed but not protruding, and there was a tear mark near the distal end side and middle of the interior of the biopsy channel.Per the legal manufacturer, these device defects have no potential to cause or contribute to death or serious injury if the malfunctions were to recur.

Event Description

The customer reported that, during reprocessing, the subject device failed leak testing.Black marks were also noticed at the distal tip and the case was slightly melted in that area.The subject device was sent to an olympus service center for evaluation.During inspection and testing, service found debris at a void in the adhesive on the bending section cover.This report is being submitted for the malfunction found during evaluation (foreign material).There was no harm or user injury reported due to the event.

• 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: 15141822
• MDR Text Key: 304879018
• Report Number: 9610595-2022-00500
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170403385
• UDI-Public: 04953170403385
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: Other
• Type of Report: Initial
• Report Date: 08/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2022
• 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: 05/02/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2021
• 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