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

Model Number URF-P6

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

Patient Problem Unspecified Kidney or Urinary Problem (4503)

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report was not returned to olympus for physical evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.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 - 00376.

Event Description

In the literature titled "device profile of the lithovue single-use digital flexible ureteroscope in the removal of kidney stones: overview of safety and efficacy", it is reported that one patient experienced ureteric injury during a procedure using a reusable scope (urf-p6 uretero-reno fiberscope).This study was an objective assessment of the lithovue single-use ureteroscope (boston scientific) based on available studies at the time of publication.The lithovue single-use flexible ureteroscope has comparable clinical performance to existing reusable ureteroscopes based on available data.Cost analyses suggest that benefit of single-use ureteroscopes is institution-specific, and will likely be favorable at a low volume of cases and with high local costs for repairs of reusable scopes.In the reusable scope group, one patient experienced ureteric injury.Treatment required for this injury was not reported.There is no report of device malfunction.

Manufacturer Narrative

This report is being updated to provide investigation findings.New information is reported in h6 and h10.The device history record (dhr) for the complaint device could not be reviewed since the serial number was not provided.Olympus does not ship any device that does not meet all design and safety specifications.Conclusion: the definitive cause of the reported events could not be established.There was no report of any olympus device malfunction reported in any procedure described in this study, therefore it is presumed that the cause of the reported events is not related to the device.

• Brand Name: URETERO-RENO FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 12306636
• MDR Text Key: 265998326
• Report Number: 8010047-2021-10088
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340802
• UDI-Public: 04953170340802
• Combination Product (y/n): N
• PMA/PMN Number: K172298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: URF-P6
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other