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

Model Number URF-V2

Device Problem Poor Quality Image (1408)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2019

Event Type  malfunction  

Manufacturer Narrative

The subject urf-v2 has not been returned to omsc for evaluation yet.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 during an unspecified urological surgery with the urf-v2, the abnormal image appeared on the monitor when the bending section of the subject device was angulated.The user replaced the subject urf-v2 to another unspecified device to complete the procedure.There was no report of the patient injury other than replacing the device.

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Based on evaluation performed by the local service engineer of olympus china, omsc supposed that the ccd unit did not work normally since water invasion into the subject device caused the short circuit of the ccd electrical component.The cause of water invasion is unknown.However, from the similar complaints, the broken bending tube may have damaged the covering of the bending section.Consequently it was considered that the water entered into the inside of the subject device from the damaged covering.Omsc reviewed the manufacturing history of the subject device and confirmed no irregularity.The instruction manual of the device instructs; warning never insert or withdraw the endoscope under any of the following conditions.Patient injury, bleeding, and/or perforation can result.While the endotherapy accessory extends from the distal end of the endoscope (except for using an ureteral access sheath).While the bending section is locked in position.

• 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: 8868620
• MDR Text Key: 200402592
• Report Number: 8010047-2019-02884
• 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
• Type of Report: Initial,Followup
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1