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

Model Number URF-V3

Device Problems Device Reprocessing Problem (1091); Fluid/Blood Leak (1250)

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

Event Date 09/26/2023

Event Type  malfunction  

Event Description

The customer reported to olympus that the uretero-reno videoscope had fluid invasion with no leakage (no phenomenon or abnormalities in appearance) during reprocessing.It was noted that the device was washed with cap on.After they were washed, there was water in them.There was no report of patient harm or user injury associated with this 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, a definitive root cause of the reported ¿device washed with sterilization cap on¿ issue could not be determined, however, the issue may have been the result of the user/facility reprocessing understanding differing from olympus ifu recommendation or user mishandling.The event can be prevented by following the instructions for use section below: 1.4 precautions olympus will continue to monitor field performance for this device.

Manufacturer Narrative

The device was returned to olympus for inspection, and the customer's reported issue ¿fluid invasion with no leakage¿ was confirmed.The following findings were also noted during device evaluation: dunk test failed/unable to tape the leak, bending section glue lifting, biopsy channel leaking and restriction, and insertion tube dented, failed ring gauge.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.

• 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: 17982669
• MDR Text Key: 326247943
• Report Number: 9610595-2023-15632
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170435119
• UDI-Public: 04953170435119
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2023

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: 10/09/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 10/23/2023
• Supplement Dates Manufacturer Received: 10/23/2023; 11/21/2023
• Supplement Dates FDA Received: 10/23/2023; 12/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2020
• 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