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 uretero-reno videoscope was returned to an olympus service center for evaluation with a report that there was a perforation/cut in the rubber covering.There was no patient or user harm reported.Inspection and testing found that the bending angulation locked and could not be controlled, due to wear of the angle wire.This report is being submitted for the malfunction found during the device evaluation.

Manufacturer Narrative

The device evaluation found the angulation lever did not move smoothly.There was a perforation in the instrument channel tube, likely caused by endo-therapy accessories.The adhesive on the bending cover was chipped due to deterioration from chemical/physical stress.The control grip, up/down plate, and universal cord were sticky, due to deterioration from chemical stresses from reprocessing over time.The control unit, scope cover, connecting tube, video connector, light guide connector, video cable, insertion tube rotation ring, forceps elevator, angulation lever, and grip were scratched.The light guide bundle was slipping down.The light guide rod had discoloration and was unclear.The control unit had corrosion due to fluid ingress in the body control unit.The investigation is ongoing.If additional information becomes available, this report will be supplemented accordingly.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's 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 angulation lock occurred due to abraded angulation wire was caused since the watertightness has not been maintained.The event can be detected/prevented by following the instructions for use which state: ¿ ¿chapter 3 preparation and inspection, 3.3 inspection of the endoscope¿ describes the following warning.1 straighten the bending section.2 confirm that the up / down angulation lock is placed in the free ¿f down¿ position.3 operate the up / down angulation control lever slowly in each direction until it stops.Confirm that the bending section angulates smoothly and correctly and confirm that maximum angulation can be achieved.4 operate the up / down angulation control lever slowly to its straight (neutral) position.Confirm that the bending section returns smoothly to an approximately straight position.¿ 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: 17714004
• MDR Text Key: 322999225
• Report Number: 9610595-2023-12994
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/09/2023

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-V3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/07/2023
• Initial Date FDA Received: 09/08/2023
• Supplement Dates Manufacturer Received: 10/05/2023
• Supplement Dates FDA Received: 10/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2021
• 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