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

Model Number URF-P5

Device Problems Mechanical Problem (1384); Poor Quality Image (1408); Material Deformation (2976)

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

Event Type  malfunction  

Event Description

The customer reported oes uretero-reno fiberscope was having image issue and multiple black dots on the vision, broken fiber image problem, and angulation was not good and could not angulate sufficiently.The issue was found during reprocessing.There were no reports of patient or user harm associated with this event.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was identified: forceps channel port was deformed.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegations were confirmed.The device evaluation found multiple black dots found in image, the distal end had a burn mark.The bending tube was damaged which caused the low angulation and restriction in the channel.There was corrosion and water seepage found inside the control unit and eyepiece.There were scratches on the angulation lever and the up/down plate.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see a correction to h3 of the initial medwatch.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 contact of metal parts of the endo therapy accessories and cleaning brushes with the channel port while inserting/withdrawing the accessories and cleaning brushes.The event can be detected by following the instructions for use (ifu) section: inspection of the endoscope the event can be prevented by following the ifu section: ·do not strike, bend, hit, pull, twist, or drop the endoscope¿s distal end, insertion tube, bending section, and control section with excessive force.The endoscope may be damaged and could cause patient injury, such as burns, bleeding, and/or perforation.It could also cause parts of the endoscope to fall off inside the patient.Olympus will continue to monitor field performance for this device.

• Brand Name: OES 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: 18130020
• MDR Text Key: 328029911
• Report Number: 9610595-2023-17129
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170316593
• UDI-Public: 04953170316593
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K912120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/06/2023

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-P5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/25/2023
• Initial Date FDA Received: 11/14/2023
• Supplement Dates Manufacturer Received: 11/20/2023
• Supplement Dates FDA Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2006
• 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