MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO VIDEOSCOPE; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number URF-V3R

Device Problems Difficult to Remove (1528); Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 03/12/2021

Event Type  Injury  

Event Description

Patient underwent a ureteroscopic laser lithotripsy.Surgeon was unable to remove ureteroscope from the ureter and after several attempts an 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: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2400 ringwood ave.; san jose CA 95131
• MDR Report Key: 11581007
• MDR Text Key: 242701979
• Report Number: 11581007
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/24/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 15028 DA