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

Model Number URF-P6R

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus and evaluation is pending.If additional information becomes available at a later time, this report will be supplemented.

Event Description

It was reported that during reprocessing, the bending section of the device was found to have a broken tip.Per the customer, metal was protruding.

Manufacturer Narrative

This supplemental report was submitted to provide the evaluation results and correction to mdr# 8010047-2020-06779.The evaluation was completed and found the scope failed the leak test; leaking at the seam of the distal end cover and bending section.Additionally, the bending section cover was stretched.The customer received a new full factory refurbishment scope via repair/exchange.The oem conducted an investigation of the reported malfunction "insertion tube braids or bending mesh protrude outward".However, after review of the it was confirmed that there was no bending section cover breakage and there was no broken/curved insertion tube problem; therefore, this report has been determined to be non-reportable malfunction.

• Brand Name: URETERO-RENO FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10573678
• MDR Text Key: 208133605
• Report Number: 8010047-2020-06779
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• PMA/PMN Number: K172298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 11/25/2020

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-P6R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/01/2020
• Initial Date FDA Received: 09/23/2020
• Supplement Dates Manufacturer Received: 10/29/2020
• Supplement Dates FDA Received: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1