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

Model Number URF-P7

Device Problem Contamination (1120)

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

Event Type  malfunction  

Manufacturer Narrative

The suspect device was returned to an olympus service center for evaluation.During evaluation of the device, the user's report was not confirmed.However, service identified the following issues: it was observed that there was air and/or water leakage from the channel due to perforation from an accessory, angulation was out of specification due to the angle wire being stretched, there was evidence of fluid invasion in the device from the body control unit, there was a broken fiber and damage to the insertion section due to physical stress, there were spots in the image due to abnormality of the image guide, and damage at the eyepiece and control sections due to physical stress and chemical stress during cleaning, disinfection, and sterilization.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.

Event Description

The customer reported to olympus that after cleaning, brown liquid came out from around the cap.The issue was identified during reprocessing.There was no harm or user injury reported due to the event.

Manufacturer Narrative

The suspect device was returned to an olympus service center for evaluation.During evaluation of the device, the user's report was not confirmed.However, service identified the following issues: it was observed that there was air and/or water leakage from the channel due to perforation from an accessory, angulation was out of specification due to the angle wire being stretched, there was evidence of fluid invasion in the device from the body control unit, there was a broken fiber and damage to the insertion section due to physical stress, there were spots in the image due to abnormality of the image guide, and damage at the eyepiece and control sections due to physical stress and chemical stress during cleaning, disinfection, and sterilization.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.

Event Description

The customer reported to olympus that after cleaning, brown liquid came out from around the cap.The issue was identified during reprocessing.There was no harm or user injury reported due to the event.

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.The device met all specifications at the time of shipment.It has been over 3 years since the subject device was manufactured.Based on the results of the investigation, the cause of the brown liquid from the cap likely occurred from an air leak in the biopsy channel which caused corrosion in the control unit.The cause of the air leak in inner wall of biopsy channel likely occurred from the insertion/withdrawal of endo-therapy into the biopsy channel while it was still open which may have damaged the inner wall.The specific root cause could not be determined at this time.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This supplemental report is being submitted to correct the manufacture name, address in d3 and g1 to aizu olympus co., ltd.In addition, this report is to correct the initial and supplemental 01 reports submitted under mfr.Number 8010047-2022-02245 to mft.Reporting registration number to 9610595.

• 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 965-8 520; JA 965-8520
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13419094
• MDR Text Key: 285641069
• Report Number: 8010047-2022-02245
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/14/2022

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: 01/28/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/18/2022
• Initial Date FDA Received: 02/01/2022
• Supplement Dates Manufacturer Received: 07/07/2022; 07/08/2022
• Supplement Dates FDA Received: 07/08/2022; 07/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2019
• 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