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

Model Number URF-V3R

Device Problems Device Reprocessing Problem (1091); Improper or Incorrect Procedure or Method (2017)

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

Event Date 03/20/2023

Event Type  malfunction  

Event Description

During a reprocessing in-service conducted on-site by olympus, the customer informed that the bw-400b single use cleaning brush was used as a reusable brush.The customer was advised that bw-400b is a single use cleaning brush and they should not be reusing it.This report is being submitted to capture the complaint on device reprocessed following incorrect procedure.There was no patient involvement.

Manufacturer Narrative

The device will not be returned.The investigation is ongoing.A supplemental will be submitted on completion of investigation or if any additional information is received.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.20 march 2023, an endoscopy support specialist (ess) performed an in-service that covered the guidelines on reprocessing the olympus scopes per the on-track and manuals.The staff also performed a return demonstration to show they understood the process.The customer also understood that the olympus reprocessing manuals are the validated source of instructions.Three attempts were performed to obtain additional information, but no response was received from the customer.The device history record was unable to be reviewed however, the arp refurbish record was reviewed and deviations that could have caused or contributed to the reported issue.Olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the likely cause of the reported event is due to the users¿ understanding differed from olympus recommendation in device handling and/or reprocessing steps.Olympus specialized staff already provided training in the correct handling.However, the root cause of the reported event is unable to be determined.The event can be prevented by following the instructions for use (ifu) which state: urf-v3/v3r reprocessing manual states on single use single-ended cleaning brush (bw-400b).If additional information becomes available, this report will be supplemented accordingly.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: 16683781
• MDR Text Key: 313235731
• Report Number: 9610595-2023-05629
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170403392
• UDI-Public: 04953170403392
• 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: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 06/09/2023

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-V3R
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/20/2023
• Initial Date FDA Received: 04/05/2023
• Supplement Dates Manufacturer Received: 05/19/2023
• Supplement Dates FDA Received: 06/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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