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

Device was received and evaluated.Evaluation determined that the device was found with a leak at ¿a-rubber¿ unit.In addition, broken skeleton, metal protruding found in the bending section.The identified parts were replaced, device was repaired.Once completed, the device was tested and passed all required testing and specifications.Root cause of the reported failure likely attributed to user's maintenance and or handling issue.

Event Description

It was reported that during reprocessing, the device was found with water leakage.The leak was coming from the distal tip.There was no patient involvement on this report.No user injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the review of the device history records (dhr) and investigation conclusion.Please see updated sections:,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 breakage and detailed ways of inspections are described.If the user follows the instructions about operation and inspection of the endoscope, the bending tube¿s breakage 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.As stated on the ifu (instruction for use) and as a preventive measure, the user manual states: inspection of the endoscope : inspect the external surface of the entire insertion section, including the bending section and the distal end for dents, bulges, swelling, scratches, peeling of coating, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities.In order to prevent the reported event occurrence, ifu ¿instructions for safe use¿ states how to manipulate the device safely.Bending tube breakage can be decreased by manipulating the device in accordance with 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: 10819550
• MDR Text Key: 224628038
• Report Number: 8010047-2020-08760
• 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: 12/10/2020

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: 09/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 11/10/2020
• Supplement Dates Manufacturer Received: 12/07/2020
• Supplement Dates FDA Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1