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

Model Number URF-V3R

Device Problem Entrapment of Device (1212)

Patient Problem Physical Entrapment (2327)

Event Date 03/12/2021

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has not yet been returned to olympus for evaluation (although it is anticipated).The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.This event has been reported by the importer on mdr# 2951238 - 2021 - 00311.

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.

Manufacturer Narrative

This report is being updated to provide additional information received.New information is reported in b5.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer¿s investigation and the results of the device history records (dhr) review.The dhr for this device were reviewed and all records indicated the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Olympus could not reproduce the reported event since the subject device was not returned.Since the device was not sent to olympus, device inspection was not conducted.Since olympus could not inspect the device, whether nonconformity of the device existed or not was unknown.Therefore, olympus could not confirm the evident relationship between the subject device and the reported event.A definitive root cause was not identified.Based on the available information, the legal manufacturer determined the probable cause of the failure is likely due to stones stuck in between the patient's ureter and the device and/or between the access sheath and the device, causing the device to get stuck inside the patient.The user may have reduce/ prevent occurrence of the suggested event by handling the device in accordance with the following instructions for use: if the endoscope or endotherapy accessory cannot be withdrawn from the patient smoothly, do not attempt to forcibly withdraw it.Rather, withdraw the endoscope or endotherapy accessory carefully.If the endoscope or endotherapy accessory cannot be withdrawn from the patient, consider removing it through open surgery and take proper measures.Forcibly withdrawing the endoscope or endotherapy accessory may cause patient injury, bleeding, and/or perforation.If any irregularity with the endoscope or endotherapy accessory is observed, contact olympus.

• 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: 11604989
• MDR Text Key: 248808706
• Report Number: 8010047-2021-04467
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170403392
• UDI-Public: 04953170403392
• Combination Product (y/n): N
• PMA/PMN Number: K181451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 07/07/2021

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?: No
• Date Manufacturer Received: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention