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

Model Number URF-V

Device Problem Material Protrusion/Extrusion (2979)

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

Event Date 10/10/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the reported event was confirmed due to water invasion that entered the device through the perforated bending section cover.In addition to the damaged metal braid of the bending tube, it was found that the charged coupled device unit was broken.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

It was reported that there was blistering at the distal end of the uretero-reno videoscope during reprocessing.There was no report of patient harm.The device was returned, evaluated, and the metal braid of the bending tube was damaged.This mdr is being submitted to capture the reportable malfunction found during the device evaluation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation and correction to h4.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 metal braid of the bending tube could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17999968
• MDR Text Key: 326507429
• Report Number: 3002808148-2023-11742
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340321
• UDI-Public: 04953170340321
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/09/2023

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-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 10/24/2023
• Supplement Dates Manufacturer Received: 11/06/2023
• Supplement Dates FDA Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2022
• 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