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

Model Number URF-V2

Device Problems Corroded (1131); Mechanical Problem (1384)

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

Event Type  malfunction  

Manufacturer Narrative

No additional information was available.The device was evaluated, and the reported issue was confirmed.Due to a pinhole on the channel tube, the water tightness was lost.Residual liquid or foreign material came out of the channel tube.The distal end had discoloration.The adhesive on the bending section cover had a chip.The universal cord had a dent, a scratch, and was sticky.The up/down plate was sticky the control unit was sticky due to water leakage.The light guide bundle was slipping down.Due to damage on the objective lens, a foggy image occurred.Due to a cut on the charge-coupled device cable, the color tone of the image was not proper.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The distributor reported the uretero-reno videoscope had an air leak.No patient injury or procedure impact reported.During the evaluation of the device it was noted, due to corrosion on the angle mechanism, the bending section could not be controlled at all.This report is to capture the reportable malfunction of the corrosion on the angle mechanism, the bending section could not be controlled at all noted at estimation.

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 damaged bending tube could not be determined, but it was likely caused by rust at the drive section.In addition, the residue/foreign material in the channel could not be identified and the root cause could not be determined, however, it is probable that the foreign material was the result of the damaged bending tube.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: 15914460
• MDR Text Key: 308155061
• Report Number: 9610595-2022-04869
• 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: User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2023

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: 11/06/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/06/2022
• Initial Date FDA Received: 12/05/2022
• Supplement Dates Manufacturer Received: 02/10/2023
• Supplement Dates FDA Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2018
• 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