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 Perforation (2001); Urinary Tract Infection (2120)

Event Date 01/13/2022

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has not been 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 information.

Event Description

It is reported in the literature titled ¿bilateral same-session flexible ureteroscopy for renal stones: a feasible method¿, patients experienced adverse events during/after procedures using an olympus uretero-reno videoscope.Background/aim: a staged ureteroscopic procedure is generally preferred to treat bilateral renal stones.In this study, we evaluated the feasibility of bilateral same-session flexible ureteroscopy (bs-furs) in renal stones.Method: a total of 81 patients underwent bilateral bs-furs between march 2014 and march 2021 for bilateral renal stones.The mean stone burden per patient was 17±4 (range 7¿27 mm).The average stone density was 1240 hu (970 to 1510).We used 4 types of ureteroscopes: olympus urf-v2 (34 cases), storz flex x2 (30 cases), single-use pusen pu 3022 (12 cases), and single-use pusen ¿ pu 3033a (5 cases).We specifically set our holmium laser for dusting, pop-corning, and fragmenting.We found 31 calcium oxalate monohydrate cases, 11 calcium oxalate dehydrate cases, 17 uric acid cases, and 22 magnesium ammonium phosphate cases.The mean operating time was 77 min.(range 52 to 85) for both renal units.The sfrs were evaluated between 1 and 3 months with computed tomography (fragments >3 mm were defined as residual).Double j stenting (6fr.) was applied bilaterally in 8 cases (9.87%) and unilateral in 34 cases (41.97%).Results: the overall sfrs after 1 and 2 procedures were 81.48% (66/81 cases) and 92.59% (75/81 cases), respectively.Postoperative complications after an overall 96 procedures were clavien i-ii (18.75%) and clavien iii (3.12%).Urinary tract infections were observed in 13 cases (16.04%) without any case of urosepsis.Conclusion: the study results suggested some bs-furs advantages as a single anesthetic session and potentially reduced cost associated with treatment.Bs-furs seem feasible, especially for medium-sized bilateral renal stones in high-volume centers.Intraoperative complications were represented mainly by mild ureteral injuries (16 cases) and small perforation of the pyelocaliceal system (1 case).Complications were evaluated using the clavien-dindo modified system for urological procedures.Postoperative complications graded as clavien i and ii represented 18.75% and clavien iii 3.12% after performing 96 interventions during session 1 and 2.There were no cases registered with clavien iv or v.There were minimal complications registered, including clavien i and ii, mostly related to postoperative pain or fever, and appropriate modifications of the treatment scheme successfully resolved these issues.There were 12 (12.5%) cases of postoperative pain included in clavien i and 6 (6.25%) cases of postoperative fever and mild hematuria, graded clavien ii.Clavien iii complications referred to double j stenting or repositioning under local anesthesia.All patients resumed a normal course after proper medical care.There is no report of any olympus device malfunction in any procedure described in this study.

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.Required follow up to obtain additional information about the event was completed.However, no new information was received from the customer.Additional information added since the initial medwatch submission to d4 and d8.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: 14680697
• MDR Text Key: 294877711
• Report Number: 8010047-2022-09954
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170343582
• UDI-Public: 4953170343582
• 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,Study,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/16/2022

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: 05/18/2022
• Initial Date FDA Received: 06/13/2022
• Supplement Dates Manufacturer Received: 07/27/2022
• Supplement Dates FDA Received: 08/16/2022
• 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