MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO VIDEOSCOPE

Model Number URF-V2

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to omsc but was returned to olympus (b)(4).(okr) for repair.Okr inspected the device and confirmed the following; -the channel was damaged and there was a leakage at the channel.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed by the user that during the procedure, some liquid came out of the channel of the device.There was no report of patient injury associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.From the inspection result of the device by olympus korea co., ltd., olympus medical systems corp.(omsc) confirmed the following: -the inside of the instrument channel was corroded.-there was a leakage at the bending section rubber due to a pinhole.-there was a leakage at the instrument channel.-the inside of the device was corroded.The exact cause of the reported event could not be conclusively determined, because the device has not been returned to omsc.From the above information, there is possibility that water entered the device from the leak point and the metal inside the device was corroded.Omsc concluded that the corrosives and water then mixed into the perforated part of the instrument channel, and came out of the instrument channel at the distal end of the device.The instruction manual provides preventive measures against the reported failure mode.Device history record (dhr) review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.If additional information becomes available, this report will be supplemented.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11159942
• MDR Text Key: 243271496
• Report Number: 8010047-2021-01278
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• PMA/PMN Number: K172246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: URF-V2
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1