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

Model Number URF-V

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

Patient Problems Sepsis (2067); Septic Shock (2068); Unspecified Kidney or Urinary Problem (4503)

Event Date 01/10/2022

Event Type  Injury  

Event Description

Olympus reviewed the following article, "single-use vs.Reusable digital flexible ureteroscope to treat upper urinary calculi: a propensity-score matching analysis" by fang huang et al.Objective: the purpose of this research was to compare the treatment outcomes and costs of a single-use and reusable digital flexible ureteroscope for upper urinary calculi.Methods: four hundred forty patients with reusable digital flexible ureteroscope and 151 patients with single-use flexible digital ureteroscope were included in this study.Through exclusion and inclusion criteria and 1:1 propensity-score matching analysis based on baseline characteristics, ultimately, 238 patients (119:119) were compared in terms of treatment outcomes.The cost analysis was based on the costs of purchase, repair, and reprocessing divided by the number of all procedures in each group (450 procedures with reusable digital flexible ureteroscope and 160 procedures with single-use digital flexible ureteroscope).Results: there was no statistical significance in mean operation time (p = 0.666).The single-use digital flexible ureteroscope group has a shorter mean length of hospital stay than the reusable digital flexible ureteroscope group (p = 0.026).And the two groups have a similar incidence of postoperative complications (p = 0.678).No significant difference was observed in the final stone-free rate (p = 0.599) and the probability of secondary lithotripsy (p = 0.811) between the two groups.After 275 procedures, the total costs of a single-use flexible ureteroscope would exceed the reusable flexible ureteroscope.Conclusion: our data demonstrated that the single-use digital flexible ureteroscope is an alternative to reusable digital flexible ureteroscopy in terms of surgical efficacy and safety for upper urinary calculi.In terms of the economics of the two types of equipment, institutions should consider their financial situation, the number of furs procedures, the volume of the patient¿s calculus, surgeon experience, and local dealerships¿ annual maintenance contract when making the choice.The authors used 1 olympus scope urf-v in the procedures and reported the following adverse events: urosepsis requiring antibiotics (n=3).Steinstrasse requiring surgical treatment (n=1).Septic shock (n= 2).Infection related complication (mod to severe urosepsis or septic shock) (n=5).

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.

Manufacturer Narrative

Correction b3: update to event date to date of article publication.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 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.

• 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: 13869637
• MDR Text Key: 293144646
• Report Number: 8010047-2022-04892
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340321
• UDI-Public: 04953170340321
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K072957
• 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: 05/19/2022

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-V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/23/2022
• Initial Date FDA Received: 03/23/2022
• Supplement Dates Manufacturer Received: 04/19/2022
• Supplement Dates FDA Received: 05/20/2022
• 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