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

Model Number URF-V2R

Device Problem Mechanical Jam (2983)

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

Event Type  malfunction  

Event Description

It was reported to olympus, that the uretero-reno videoscope had leakage in the scope.The issue was found during maintenance.Inspection and testing of the returned device found that the angulation became locked due to deterioration of the angulation mechanism due to corrosion.There was no patient harm or user injury reported.This mdr is being submitted to capture the reportable malfunction found during the device evaluation.

Manufacturer Narrative

The device was returned for evaluation and the customers allegation was not confirmed.It was noted that water tightness was lost due to damage on the channel tube and the bending tube could not be fixed firmly due to damage to the forceps elevator lever.The light guide connector had corrosion and the universal cord had discoloration.The control unit had corrosion due to water leakage.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, it is likely that the following led to the malfunction: it was presumed that the issue occurred due to corrosion of internal mechanism caused by fluid invasion on the control unit.It was presumed that fluid invaded from the leaking area or fluid invaded from the venting connector such as by detaching a leakage tester in water at leakage test.However, a definitive root cause cannot be identified.This issue is addressed in the instructions for use (ifu): user can detect the suggested event by handling device in accordance with ifu ¿operation manual_ inspection of the endoscope_ inspection of the angulation mechanism¿.User may be able to prevent the suggested event by handling device in accordance with the following ifu.Reprocessing manual_ leakage testing of the endoscope_ perform the leakage test - do not attach/detach the leakage tester while immersing the endoscope in the water.- if you identify a leak during leakage testing, remove the endoscope from the water with both the venting connector and the leakage tester still attached.Contact olympus regarding instructions for reprocessing a leaking endoscope in preparation for returning the endoscope to olympus for repair.Olympus will continue to monitor the field performance of this device.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• 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: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18160676
• MDR Text Key: 329700035
• Report Number: 9610595-2023-17559
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170343612
• UDI-Public: 04953170343612
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K172246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/17/2023

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-V2R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/31/2023
• Initial Date FDA Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2017
• 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