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

Model Number URF-V3R

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/12/2021

Event Type  Injury  

Event Description

It is reported during an unspecified procedure using an uretero-reno videoscope, the scope became stuck inside the patient.The physician changed to an open approach to finish the procedure and remove the entrapped device.In the process of removing the entrapped device, part of the patient's ureter was removed.Efforts were made to request additional details regarding the patient and event.The customer responded "we have reported this event through medsun.Information regarding the event will be shared with you through that process".

Event Description

On 12apr2021 olympus received voluntary (b)(4) submitted to the fda by the user facility.Description of event: patient underwent a ureteroscopic laser lithotripsy.Surgeon was unable to remove the ureteroscope from the ureter and after several attempts, and exploratory laparotomy was performed.Surgeon noted distal sheath on the scope bunched and formed a ring that was caught on the ureteral mucosa.The left ureter was avulsed.

• 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: 11604790
• MDR Text Key: 243463108
• Report Number: 2951238-2021-00311
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170403392
• UDI-Public: 04953170403392
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 03/15/2021,05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-V3R
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/15/2021
• Date Report to Manufacturer: 03/15/2021
• Date Manufacturer Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention