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

Model Number URF-V2

Device Problem Scratched Material (3020)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus for evaluation.During inspection and testing, the allegation of leakage was confirmed.Due to a pinhole on channel tube, water tightness was lost.In addition to evaluation, distal end had a burn.The grip plwas sticky.The up/down plate was sticky.Universal cord was sticky.The control unit had a scratch.Grip had a scratch.Universal cord had a scratch.The control unit had corrosion due to water leakage.Due to damage, the angulation lever did not move smoothly.Due to damage on channel tube, forceps could not be inserted smoothly.Due to damage on the channel tube, channel cleaning brush could not be inserted smoothly.Light guide bundle was slipping down.Switch button 3 was not functioning due to switch button 3 failure.Connecting tube had a scratch.The video connector case had a scratch.The video connector had a scratch.Light guide connector had a scratch.The protector of the video cable section had a scratch.The video cable had a scratch.The insertion tube rotation ring had a scratch.Angulation lever had a scratch.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

An olympus employee reported on behalf of a customer, the uretero-reno videoscope had a flaw in forceps channel and air bubbles appear in leak test.There was no report of user or patient harm associated with this event.During incoming inspection, it was determined the forceps plug mouthpiece was scraped due to physical stress.This medwatch is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the root cause of the observed scraped off forceps plug mouthpiece could not be determined, however, it is likely that the plug damage was the result of repetitive use stress, external factors, or handling.The event can be detected by following the instructions for use which state: "chapter 3 preparation and inspection 3.3 inspection of the endoscope".¿inspection of endoscope¿ ¿1.Visually check that there are no large scratches, deformations, loose parts, or other abnormalities on the appearance of the operation unit, video connector, and light guide connector.2, visually check that the electrical contacts on the video connector are not corroded.3.Visually confirm that there are no bends, twists, bulges, or other abnormalities near the boundary between the oredome part and the insertion part.4.Cracks, dents, bulges, edges, scratches, peeling of coating material, metal wires protruding from the inside, protrusions, sagging, deformation, bending, adhesion of foreign matter on the outer surface of the entire length of the insertion part including the curved part and tip., visually confirm that there are no abnormalities such as missing parts.5.Grasp the insertion part lightly with your hand, slide it in both directions over the entire length, and check by hand that there is no catching or protruding metal wire from the inside.Also, check by feeling that the flexible part is not abnormally hard¿.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: 16598869
• MDR Text Key: 311881726
• Report Number: 9610595-2023-04909
• 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: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/24/2023

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: 02/23/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/23/2023
• Initial Date FDA Received: 03/23/2023
• Supplement Dates Manufacturer Received: 03/28/2023
• Supplement Dates FDA Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2018
• 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