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

Model Number URF-V2

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

Patient Problems Sepsis (2067); Renal Impairment (4499)

Event Date 08/03/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Olympus reviewed the following article: "the "no-touch" technique in the flexible ureteroscopic approach of renal stones."   the present study focused on the technical aspects, advantages, drawbacks, and limitations of the latest ¿no-touch¿ technique (ntt) in the flexible ureteroscopic therapeutic approach of renal stones.A total of 288 patients with a single pyelocaliceal stone (largest diameter between 11 and 29 mm) underwent furs: 144 using the 12/14 fr uas (group 1) and 144 without uas (group 2).For ntt, used four types of ureteroscopes: olympus urf-v2 (8.5 fr) ¿ 33 cases, storz flex x2 (8.4 fr) ¿ 60 cases, single-use pusen pu 3022 (9.5 fr) ¿ 37 cases, and single-use pusen ¿ pu 3033a (7.5 fr) ¿ 14 cases.For group 1, used the olympus urf¿v2 ureteroscope in 44 cases, the storz flex x2 in 58 cases, and the single-use pusen pu 3022 in 42 cases.This study compared the operative time, hospitalization periods, and complications.Successful access sheath insertion was noted in 83.3% of cases from group 1, and successful ureteroscope insertion was noted in 90.9% of cases from group 2.The average operative time was slightly higher in group 1 vs.Group 2 (47 vs.39 min).Stone-free rates (sfrs) were overall lower in group 2 (76.3% vs.86.8%) at 1 month.Superficial mucosal ureteral wall lesions were found in 38.8% of patients from group 1 and 4.1% from group 2.Hospitalization periods were longer in group 1 vs.Group 2 (21 vs.29 hours, respectively).The single-use 7.5 fr ureteroscope should receive a special mention: the insertion was simple, we did not encounter any mucosal ureteral wall lesions, and all patients were discharged on the same day.Despite the clear advantages of routine uas usage, there are many adverse events for the patient.Larger diameter sheaths involve a greater risk of ureteral wall injury.Ntt seems to improve peri- and postoperative safety while preserving therapeutic efficiency.The new 7.5 fr ureteroscopes appear to optimize surgical efficiency and diminish complications in the flexible ureteroscopic treatment of renal stones.    type of adverse events/number of patients clavien iiia complications (4 in group 1 and 1 in group 2), renal colic requiring double j stenting (count not reported), clavien ii (15 in group 1 and 18 in group 2), sepsis - (1) ,urinary tract infections - (29), ureteral stent discomfort - (3).

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 lot number could not be confirmed at this time.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.

• 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: 14278616
• MDR Text Key: 293695801
• Report Number: 8010047-2022-07509
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170343582
• UDI-Public: 04953170343582
• Combination Product (y/n): N
• Reporter Country Code: RO
• PMA/PMN Number: K172246
• 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: 06/29/2022

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-V2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/10/2022
• Initial Date FDA Received: 05/04/2022
• Supplement Dates Manufacturer Received: 06/06/2022
• Supplement Dates FDA Received: 06/29/2022
• 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
• Patient Outcome(s): Other