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

Model Number URF-V2R

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation.A broken cable with the support metal protruding from the distal sheath of the bending section was identified.The cause of the metal protrusion issue cannot be determined at this time.If additional information becomes available at a later time, this report will be supplemented.

Event Description

It was reported the device was returned due to failing the leak test during reprocessing and having an open area at the tip.

Manufacturer Narrative

This supplemental report is being submitted to provide the review of the device history records (dhr) and investigation.Please see updated sections: d4, g4, g7, h2, h3,h4, h6 and h10.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.A root cause cannot be conclusively determined.However, in instructions for use (ifu),ways of handling which may result in the bending tube¿s damage and detailed ways of inspections are described.If the user follows the instructions about operation and inspection of the endoscope, the bending tube¿s damage can be eliminated and any abnormality can be detected safely.The probable cause for this damage is likely that there was deviation from the following description stated in ifu.Olympus will continue to monitor complaints for this device.

• 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: 10344016
• MDR Text Key: 201010679
• Report Number: 8010047-2020-05030
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/08/2021

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-V2R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/11/2020
• Initial Date FDA Received: 07/30/2020
• Supplement Dates Manufacturer Received: 12/11/2020
• Supplement Dates FDA Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1