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

Model Number URF-P5

Device Problems Entrapment of Device (1212); Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 10/14/2019

Event Type  Injury  

Event 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
• 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: 9578241
• MDR Text Key: 174668737
• Report Number: 2951238-2020-00313
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170286988
• UDI-Public: 04953170286988
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/19/2019,01/10/2020

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
• Device Operator: Health Professional
• Device Model Number: URF-P5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 79