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

Model Number URF-P7

Device Problem Material Deformation (2976)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned and evaluated by olympus.In addition to the findings, evaluation found the complaint was not confirmed.Evaluation did find the distal end was burned, the bending section cover adhesive was chipped, the bending angle in the up direction did not meet the standard value due to wear of the angle wire, the image was stained, due to damage on the image guide bundle, and multiple parts of the scope were scratched.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Event Description

The customer reported the image of the uretero-reno fiberscope had 7 black dots.There was no reported patient harm or impact due to this event.During device evaluation at olympus, it was found the forceps channel port was shaved.The report is being submitted due to the shaved port found during evaluation.

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, the root cause of the reported event is unable to be determined.However, the cause of the event is likely due to stress of repeated use, external factors or handling of the device.The event can be detected by following the instructions for use (ifu) which state: ¿ chapter 3 preparation and inspection, 3.3 inspection of the endoscope¿ describes the following.[inspection of the endoscope] 1.Inspect the eyepiece section and appearance of the control section for excessive scratching, deformation, loose parts, or other irregularities visually and with touching.2 inspect the eyepiece lens and the cover glass of the light guide connector for any irregularities such as scratches, cracks, and stains.3 inspect the boot and the insertion section near the boot for any irregularities such as bends, twists, tears, and cracks.4 inspect the external surface of the entire insertion section including the bending section and the distal end for any irregularities such as dents, bulges, swelling, scratches, peeling of coating, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, and protruding objects.5.Holding the control section with one hand, carefully run your other hand back and forth over the entire length of the insertion section.Confirm that no objects or metallic wire protrude from the insertion section.Also, confirm that the insertion tube is not abnormally rigid.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: 16494808
• MDR Text Key: 311502295
• Report Number: 9610595-2023-03838
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170403811
• UDI-Public: 04953170403811
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K181451
• 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,Followup
• Report Date: 04/11/2023

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-P7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/12/2023
• Initial Date FDA Received: 03/07/2023
• Supplement Dates Manufacturer Received: 03/17/2023
• Supplement Dates FDA Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2020
• 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