MAUDE Adverse Event Report: OLYMPUS CORPORATION OF THE AMERICAS / OLYMPUS MEDICAL SYSTEMS CORPORATION OLYMPUS URETEROSCOPE; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number URF-V2-W

Device Problems Break (1069); Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/15/2020

Event Type  malfunction  

Event Description

Md was using 200 micron laser fiber in ureteroscope, and fiber did not fit correctly.Md changed to 365 micron fiber when lasering in other ureter, and small piece of fiber broke off, possibly due to scope.Retrieval of fragment was attempted: md was able to get fragment into basket, but piece fell out during removal.Md attempted to find fiber fragment, but was unable.Fda safety report id# (b)(4).

• Brand Name: OLYMPUS URETEROSCOPE
• Type of Device: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): OLYMPUS CORPORATION OF THE AMERICAS / OLYMPUS MEDICAL SYSTEMS CORPORATION
• MDR Report Key: 10447973
• MDR Text Key: 204351684
• Report Number: MW5096215
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/20/2020

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 Expiration Date: 04/07/2023
• Device Model Number: URF-V2-W
• Device Lot Number: KR933656
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Weight: 47