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 Urinary Tract Infection (2120); Hematuria (2558)

Event Date 01/04/2022

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report was not returned to olympus for 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.

Event Description

It is reported in the literature titled ¿outcomes of retrograde intrarenal surgery in renal calculi of varying size,¿ patients experienced adverse effects during and retrograde intra renal surgery procedures.Introduction: technological advancements have made it possible to attempt retrograde intrarenal surgery (rirs) in patients with large renal calculi.The objective of this study was to compare the intraoperative adverse events, postoperative complications, and stone free rates (sfr) of rirs in patients with renal calculi of varying sizes.Methods: patients who underwent rirs for renal calculi between january 2016 and june 2020 were categorized into six size groups according to the longest dimension or cumulative measurement of the longest dimension of calculi as follows: group 1 (1¿9 mm), group 2 (10¿19 mm), group 3 (20¿29 mm), group 4 (30¿39 mm), group 5 (40¿49 mm) and group 6 (=50 mm).All the patients were followed up for a period of 6 months post treatment completion and the outcomes of interest were computed and compared.Results: two hundred and ten patients were included in the analysis.Intraoperative adverse events were noted in 9.5%, 8%, 16.9%, 9.1%, 6.7% and 28.6% of the patients in groups 1¿6, respectively (p = 0.453).The postoperative complications were noted in 4.8%, 5.3%, 6.8%, 15.2%, 26.7% and 42.9% of patients in groups 1¿6, respectively (p = 0.024).The final sfrs were 95.2%, 100%, 96.6%, 90.9%, 86.7% and 71.4% in groups 1¿6, respectively (p = 0.012).Conclusions: rirs is an effective treatment option for the management of renal stones, including those larger than 20 mm in size.We noted a size dependent increase in the postoperative complications and a reduction in the sfrs.The majority of the postoperative complications were low grade and no stone related events occurred in the patients who were managed conservatively for residual stones after surgery, on the short term follow up.Hematuria with clots requiring prolonged catheterization and hospitalization was the most common postoperative complication in our series, which resolved spontaneously in all the cases.Hematuria was a frequent postoperative complication in a few of the other studies as well.Two patients presented with steinstrasse postoperatively and both had a dj stent in situ.One of them underwent emergency operation, while the other improved with medical management alone.Postoperative complications higher than clavien grade 2 were recorded in 2 patients.These comparatively lower rates of infective complications, as noted in our series can be attributed to the routine use of uas in all the patients, avoiding excessive irrigation pressures, setting up an upper limit for the duration of the procedure and taking up the patient only after confirming a sterile urine culture.There is no report of olympus device malfunction in any procedure described in this literature.

Manufacturer Narrative

This report is being supplemented 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 and/or lot 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.Therefore, the root cause cannot be determined.Olympus will continue to monitor field performance for this device.

• 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: 15312423
• MDR Text Key: 298806693
• Report Number: 9610595-2022-01410
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170403811
• UDI-Public: 04953170403811
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K181451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2023

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: 07/31/2022
• Initial Date FDA Received: 08/29/2022
• Supplement Dates Manufacturer Received: 12/22/2022
• Supplement Dates FDA Received: 01/12/2023
• 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
• Patient Outcome(s): Other