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

Model Number URF-V2

Device Problems Defective Component (2292); Detachment of Device or Device Component (2907); Failure to Clean Adequately (4048)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation of ¿defects of the distal end¿ was not confirmed.The device evaluation found residual liquid/foreign material came out of the channel tube due to insufficient cleaning.Additionally, the bending section cover had a cut.Due to a pinhole on bending section cover, water tightness was lost.Due to a pinhole on the connecting tube, water tightness was lost.The image guide protector had a cut due to physical stress.The protector of the universal cord on the scope connector side had a cut.The control unit was sticky due to water leakage.The connecting tube had a cut.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.

Event Description

An olympus marketing personnel reported on behalf of the customer that the uretero-reno videoscope had defects of distal end.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was identified: foreign object clogging in forceps channel.There were no reports of patient or user harm associated with this event.This medical device report (mdr) is being submitted to capture the reportable malfunction 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 observed foreign material in the instrument channel could not be identified and a definitive root cause of the observed issue could not be determined, as there was no observed deformation that might result in the retention of foreign material and no additional facility device reprocessing information was reported or available, however, the issue was likely the result of insufficient device cleaning/reprocessing.The event may be detected/prevented by following the instructions for use sections below: urf-v2, chapter 3 preparation and inspection.Urf-v2, chapter 5 reprocessing the endoscope olympus will continue to monitor field performance for 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18106859
• MDR Text Key: 328509238
• Report Number: 9610595-2023-16844
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170343582
• UDI-Public: 04953170343582
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172246
• 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: 11/30/2023

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-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/20/2023
• Initial Date FDA Received: 11/09/2023
• Supplement Dates Manufacturer Received: 11/17/2023
• Supplement Dates FDA Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2018
• 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