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

Model Number URF-V3

Device Problems Residue After Decontamination (2325); Failure to Clean Adequately (4048)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/29/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to the service center for evaluation; however, the device evaluation is still pending.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

As reported, a foreign substance coming out from inside the scope when used was observed.The issue found during an unspecified procedure.There is no patient harm or injury reported on this reported event.There is no patient infection associated on this reported event.No user injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information obtained from the customer and the approved final investigation.Based on the results of the device evaluation and investigation, the biopsy channel was torn and leaked, the adhesive on the bending section was chipped, and the unit failed the water dunk test.Although the definitive root cause of the reported issue could not be determined, a probable cause of the torn biopsy channel was improper laser radiation or contact by a therapeutic accessory, which may have cause a piece of carbon to be ejected from the inside of the insertion section.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: "if laser radiation is activated when the distal end of the laser prove is not visible within an endoscopic image, the device may be damaged.Do not forcibly insert endotherapy accessories.If an endoscope having leakage is used, a malfunction may occur." olympus will continue to monitor field performance for this device.

Event Description

The procedure was an unknown, diagnostic one.The procedure was completed with a short delay.The device was inspected before use, and nothing was found to be wrong with the device.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the approved final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Olympus will continue to monitor field performance for this device.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12862493
• MDR Text Key: 281164331
• Report Number: 8010047-2021-14941
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170403385
• UDI-Public: 04953170403385
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-V3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1