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

Model Number URF-V3R

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 12/03/2019

Event Type  Injury  

Event Description

The sales representative was informed by the user facility that during a procedure, the metal tip on the scope ripped the patient's ureter.The sales representative further reported that the user facility has been performing procedures using the scope as part of an evaluation to purchase the equipment.The sales representative observed the procedures as the evaluation went on for 5-6 days.There were no reported issues with the scope and no issues with any of the patients during the evaluation.However, on the last day of evaluations a technician reportedly informed the sales representative that the facility was done with the evaluations and stated the doctor tore a patient's ureter.The sales representative has not been able to obtain additional information from the user facility regarding the reported patient injury.The device was returned to the service center but the evaluation is in progress.

• 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: 9527920
• MDR Text Key: 173008038
• Report Number: 2951238-2019-01237
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170403392
• UDI-Public: 04953170403392
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/06/2019,12/27/2019

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
• Device Operator: Health Professional
• Device Model Number: URF-V3R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/06/2019
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/06/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention