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

Model Number URF-V

Device Problem Material Deformation (2976)

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

Event Type  malfunction  

Event Description

The olympus asset, flex video scope, was returned to olympus with a report that the distal end was burnt.There was no report of patient harm associated with this event.During the device inspection, it was found that the forceps stopper was chipped.This report is being submitted for the malfunction found during the device evaluation.

Manufacturer Narrative

The device evaluation found the distal end cover had a burn.Due to a chip on distal end, water tightness was lost.Adhesive on rubber had a chip.Insertion tube rotation ring was damaged.Due to wear of angle wire, bending angle in up direction did not meet the standard value.The connecting tube had a dent.Video connector case had discoloration.Video connector case had a scratch.Video connector had a scratch.Label on lg connector was peeled.Lg connector had a scratch.Protector of the video cable section had a scratch.Video cable had a scratch.The universal cord had a wrinkle and a scratch.Angulation lever had a scratch.Grip had a scratch.Insertion tube rotation ring was damaged.A review of the device history records could be reviewed because the device in question was manufactured 15 years or more ago.Based on the results of the investigation, the device deformation may have been the result of use and reprocessing of the device over time; however, a root cause could not be determined.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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18282587
• MDR Text Key: 329940065
• Report Number: 9610595-2023-18993
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K072957
• 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
• Report Date: 12/07/2023

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-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/14/2023
• Initial Date FDA Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2008
• 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