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

Model Number URF-V

Device Problems Contamination (1120); Poor Quality Image (1408); Difficult to Advance (2920); Improper Flow or Infusion (2954)

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

Event Date 05/18/2023

Event Type  malfunction  

Event Description

A user facility reported to olympus that there were defects of the distal end/connector in the uretero-reno videoscope when trying to introduce liners.It was stated that the diameter of the distal tip needed to be rectified.Additional information was obtained.It was stated that this had been encountered by the operator in a few operations with this device; it was clarified that there was a clear reduction in vision during flexible ureterorenoscopic procedures with reduced irrigation flow and associated difficult in the progression of the instrument.This created dilation of the instrument sheath.The facility had been forced to switch from the 11 french-13 french liners to the 12 french to 14 french.A specific adverse event of a procedural delay occurred on (b)(6) 2023 during a diagnostic-interventional laser procedure for "ureterolitotissia." the product was routinely inspected prior to the procedure with no abnormalities found.However, due to the above described issues, there was a 15-20 minute delay, causing the anesthesia to be prolonged.There was no harm to the patient due to this event.The procedure was completed with the same equipment.Upon inspection and testing of the customer returned device, it was observed that the biopsy channel was broken and clogged with foreign material of an unknown origin.This report is being submitted for the malfunction found during evaluation.

Manufacturer Narrative

Upon evaluation of the returned device, in addition to the broken and clogged biopsy channel, the following defects were also found: distal end defects, connector defects and a biopsy channel leak.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to the initial with information inadvertently left out.Correction to b5 of the initial medwatch which noted "a specific adverse event of a procedural delay occurred on 18-may-23 during a diagnostic-interventional laser procedure for "ureterolitotissia." per olympus clinical assessment, no adverse event occurred.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 the phenomenon of the "the procedures were completed with a delay of approximately 15 to 20 minutes" was due to the device malfunction that occurred during the procedure.The root cause of the phenomenon could not be identified.Additionally, it is likely that the phenomenon of the "broken and clogged biopsy channel with a foreign material" is due to that foreign material may not have been removed due to damage on the device.The root cause of the phenomenon could not be determined.The event can be prevented by following the instructions for use which state: "chapter 6 compatible reprocessing methods and chemical agents chapter 7 cleaning, disinfection, and sterilization procedures [do not bend, hit or twist the insertion section, control section, universal cord or video connector.The endoscope may be damaged and water leaks and/or breakage of internal parts like the ccd cable can result.If air bubbles emerge from the endoscope continuously during the leakage test, do not use the endoscope.Water may enter the instrument and cause a short circuit.This may result in breakage of the switches and ccd." 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: 17144713
• MDR Text Key: 318099428
• Report Number: 3002808148-2023-06076
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340321
• UDI-Public: 04953170340321
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/12/2023

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: 05/25/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/22/2023
• Initial Date FDA Received: 06/16/2023
• Supplement Dates Manufacturer Received: 06/21/2023
• Supplement Dates FDA Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2016
• 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