MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. URETERO-RENO FIBERSCOPE

Model Number URF-P7

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

Patient Problems Unspecified Infection (1930); Perforation (2001); Discomfort (2330); Obstruction/Occlusion (2422)

Event Date 03/14/2022

Event Type  Injury  

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article is attached for additional information.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

Olympus reviewed the following literature titled "thulium fibre laser versus holmium:yag for ureteroscopic lithotripsy: outcomes from a prospective randomised clinical trial." a prospective randomised trial was conducted to evaluate and compare outcomes after urs lithotripsy with ho:yag and tfl.A total of 120 consecutively admitted patients with signed consent were included for randomization.The primary outcome was the stone-free rate (sfr) assessed on non-contrast computed tomography at 3-mo follow-up.Secondary outcomes were the operative time and complications.After a single session, the sfr was 67% in the ho:yag group and 92% in the tfl group, p =.001.For ureteral stones, the sfr was 100% in both groups, and for renal stones; 49% (ho:yag) and 86% (tfl), p =.001.Operative time was shorter using tfl (49 min) compared to ho:yag (57 min), p =.008.Bleeding that impaired the endoscopic view was the most frequent intraoperative adverse event and occurred in 13 patients (22%) in the ho:yag group and three (5%) in the tfl group, p =.014.The study concluded that significantly more patients with renal stones achieved stone free status and fewer experienced intraoperative complications using tfl compared to ho:yag.Type of adverse events/number of patients: intraoperative complications - 21 (some patients had more than one adverse event) bleeding impairing vision 16.Mucosal abrasion 8.Early postoperative complications - 4.Postoperative complications leading to readmission - 15 (some patients had more than one cause of readmission.) infection 10.Obstruction 6: obstruction leading to dilatation of the upper urinary tract detected on non-contrast computed tomography or pain.Other 2: discomfort related to a ureteral stent or voiding difficulties.This literature article requires 3 reports.The related patient identifiers are as follows: (b)(6): tfl-pls.(b)(6): urf-v3.(b)(6): urf-p7.This medwatch report is for patient identifier (b)(6).There is no report of any olympus device malfunction in any procedure described in this study.

Manufacturer Narrative

This supplemental report is being submitted to provided additional information from the author and to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Olympus will continue to monitor field performance for this device.

Event Description

Additional information received from the author: in the medical opinion of the author, the olympus device did not malfunction nor cause the adverse events reported.

• Brand Name: URETERO-RENO FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15193741
• MDR Text Key: 297572338
• Report Number: 9610595-2022-00729
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170403811
• UDI-Public: 04953170403811
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K181451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/04/2022

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-P7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/12/2022
• Initial Date FDA Received: 08/09/2022
• Supplement Dates Manufacturer Received: 09/05/2022
• Supplement Dates FDA Received: 10/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: TFL-PLS, MEDILAS H SOLVO 30 W, DORNIER MEDTECH
• Patient Outcome(s): Other; Required Intervention