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

Model Number	URF-P5
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/14/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On december 19, 2019, the service center received medwatch report# 2019-1 that states, "patient was undergoing a cystoscopy, right retrograde pyelogram, right ureteroscopy, laser lithotripsy procedure.As the surgeon proceeded to remove the ureteral scope from the right ureter it became lodged in the mid to distal ureter.The surgeon could not free the scope without significant traction.Despite attempts, the scope remained impacted within the ureter.A 14 french foley was replaced into the bladder, and ureteral scope was secured to patient's right thigh.The patient was then transferred to tertiary facility for further evaluation and management." as part of our investigation, multiple follow-ups were made to the user facility in an attempt to gather additional information on the reported event; however, no additional information was obtained.The reported scope was not returned to the service enter for evaluation; therefore, the cause of the reported event cannot be determined a this time.

• Brand Name: OES URETERO-RENO FIBERSCOPE
• Common Device Name: 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: 9578241
• Report Number: 2951238-2020-00313
• Device Sequence Number: 16266390
• Product Code: FGB
• UDI-Device Identifier: 04953170286988
• UDI-Public: 04953170286988
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/10/2020
• Report Date (Section F): 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: URF-P5
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/19/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 79