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

Model Number URF-V2R

Device Problems Break (1069); Material Protrusion/Extrusion (2979)

Patient Problem No Information (3190)

Event Date 12/15/2020

Event Type  malfunction  

Manufacturer Narrative

The device was received by olympus.The bending section of the device was broken and metal was protruding.Additional information was requested from the customer but has not been received.This event is currently under investigation.A supplemental report will be submitted upon receiving additional information.

Event Description

It was reported the tip of the uretero-reno videoscope broke during a procedure.No information on patient impact was provided.

Manufacturer Narrative

The following fields were updated: g4, g7, h2, h10.Upon further review, the complaint described in the initial report was found to be a duplicate.This complaint and all required information was already reported under medwatch report # 8010047- 2021-01138.All subsequent information will be included in a supplemental report under medwatch report # 8010047- 2021-01138.

• 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: 11186711
• MDR Text Key: 228008186
• Report Number: 8010047-2021-01567
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170343612
• UDI-Public: 04953170343612
• 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: 01/22/2021

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: 12/18/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/19/2020
• Initial Date FDA Received: 01/18/2021
• Supplement Dates Manufacturer Received: 01/18/2021
• Supplement Dates FDA Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1