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 Date 07/06/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer¿s allegation was confirmed.The angulation knob became locked and could not be disengaged.Due to foreign objects in control section, bending section could not be controlled at all.Additionally, the investigation revealed: due to pin holes in the bending section cover and the channel tube, water tightness was lost, adhesive on bending section cover had a chip, universal cord had a dent and was sticky, the up/down plate was sticky, video cable had a scratch, the control unit was sticky due to water leakage, the light guide-bundle was slipping down and due to damage on the charged coupled device unit, a noise image occurred.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

The customer reported to olympus that uretero-reno videoscope that the user was unable to unlock angle knob during preparation for use for an unspecified procedure.There were no reports of patient harm or impact associated with the event.

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 angle knob unlocking issue could not be determined, however, water intrusion inside the scope, along with other defects such as air leak from bending section cover (a-rubber) and the instrument channel, it is likely that parts related to angulation operation were corroded and solidified.The event can be prevented by following the instructions for use which state: ¿product instruction manual (operation)¿ ¿3.3 endoscope inspection¿.¿inspection for smooth operation¿.¿ straighten the bend.Confirm that the ud angle release lever is in the free state.Slowly move the ud angle lever in each direction until it stops, then return it to its original position, and check by hand that there are no abnormalities such as rough operation, looseness, or catching.Also, visually check that the flexure bends sufficiently and smoothly to the maximum bend angle and back.Visually confirm that the bend is almost straight when the ud angle lever is in the neutral position¿.¿inspection of ud bending mechanism.¿.¿ turn the ud angle release lever in the direction opposite to "f down" until it hits.Turn the ud angle lever in the "u" or "d" direction until it stops.Check that the curved shape of the curved part is mostly fixed when you release the ud angle lever.When turning the ud angle release lever in the "f down" direction without touching the ud angle lever, check that the curved part returns to an almost straight state¿.¿product instruction manual (cleaning/disinfection/sterilization edition)¿ "1.4 general notes".¿perform a leak test on the endoscope after each pre-clean.Do not use if leaks are found.Continuing to use an endoscope that has leaked water may cause damage to the endoscope, such as sudden disappearance of the endoscopic image or malfunction of the bending mechanism.In addition, there is a risk of infection.¿.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: 16492171
• MDR Text Key: 310781765
• Report Number: 9610595-2023-03816
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/26/2023

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: 02/05/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/05/2023
• Initial Date FDA Received: 03/06/2023
• Supplement Dates Manufacturer Received: 04/03/2023
• Supplement Dates FDA Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2019
• 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