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

Model Number URF-P7R

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

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

Event Date 02/27/2023

Event Type  malfunction  

Manufacturer Narrative

Staff were in-serviced on proper pre-cleaning and leak testing steps (found in the olympus manual).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 available.

Event Description

The endoscope specialists (ess) completed a repair reduction observation at the site along with facility summary review.In-service included repair reduction information, tips, techniques, and cost.During observation, facility staff were found not performing any of the pre-cleaning steps at the end of the case using uretero-reno fiberscope.Staff were observed doing leak testing steps out of sequence in the sterile processing department.This report is being submitted to report incorrect reprocessing procedure followed by the site.There was no patient involvement.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's 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 incorrect reprocessing was the user¿s understanding differed from olympus recommendation in device handling and/or reprocessing steps.Re-training for the correct handling was completed.Olympus will continue to monitor field performance for this device.

• Brand Name: URETERO-RENO FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• 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: 16577055
• MDR Text Key: 312230124
• Report Number: 9610595-2023-04698
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170403835
• UDI-Public: 04953170403835
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/08/2023

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-P7R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/27/2023
• Initial Date FDA Received: 03/20/2023
• Supplement Dates Manufacturer Received: 04/13/2023
• Supplement Dates FDA Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2020
• 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