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

Model Number URF-P6R

Device Problem Device Reprocessing Problem (1091)

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

Event Date 12/13/2023

Event Type  malfunction  

Event Description

Olympus was informed that during an onsite visit, the user facility staff had used the single-ended cleaning brush for all the brushing steps and had been reusing this same brush until they ordered additional brushes.The customer also stated that they did not have the single use combination cleaning brush for the next brushing steps stated in the ifu (instructions for use).The issue occurred during reprocessing.The no patient infections or injuries were reported.

Manufacturer Narrative

No device was returned to olympus for evaluation.However, as part of the investigation into this report, an olympus endoscopy support specialist (ess) has been dispatched on-site to assess the reprocessing practices at the user facility.

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.It has been over five years since the subject device was manufactured.Based on the results of the investigation, it was presumed that there was a difference in recognition about the device handling and reprocessing steps between recommendations made by olympus and the user facility.Training was conducted by an endoscopy support specialist for proper handling.Occurrence of the event can be prevented by handling the device according to the following ifu.- ifu: urf-p6r reprocessing manual chapter 5 reprocessing the endoscope.Olympus will continue to monitor the field performance of 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: 18417266
• MDR Text Key: 331594237
• Report Number: 9610595-2023-20565
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340833
• UDI-Public: 04953170340833
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 02/02/2024

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-P6R
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 12/29/2023
• Supplement Dates Manufacturer Received: 01/24/2024
• Supplement Dates FDA Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/03/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1