MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. URETERO-RENO VIDEOSCOPE

Model Number URF-V

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

Patient Problems Hematoma (1884); Unspecified Kidney or Urinary Problem (4503)

Event Type  Injury  

Event Description

Olympus reviewed the following literature titled "retrospective analysis of stone basket combined with flexible ureteroscope holmium laser lithotripsy in the treatment of lower calyceal stones".Literature summary: the study was aimed to investigate the efficacy of stone baskets combined with flexible ureteroscope holmium laser lithotripsy (furl) in the treatment of lower calyceal stones (lcs).A total of 216 patients with lcs who underwent furl were analyzed and divided into observation group (n=129) and control group (n=87).The short term stone clearance rate (85.27% vs.66.67%) and long-term stone clearance rate (95.35% vs.85.06%) of the observation group were significantly higher than those of the control group; the incidence rate of steinstrasse (0% vs.8.05%) and overall complications (7.75% vs.16.09%) in the observation group were significantly lower than those in the control group.This study concluded that stone basket combined with furl was safe and feasible for the treatment of lcs, which could improve the stone clearance rate and reduce the risk of steinstrasse formation after the operation.Type of adverse events/number of patients, observation group (n = 129), fever - 7 patients, renal colic - 3 patients.Control group (n = 87), fever - 5 patients, renal colic - 7 patients, perinephric hematoma - 2 patients.The author used an unknown model of olympus electronic ureteroscope.Model urf-v was selected as a representative product.

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

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.This supplemental report includes information added to g2.Olympus will continue to monitor field performance for this device.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15317192
• MDR Text Key: 298873678
• Report Number: 9610595-2022-01430
• 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,Study,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/22/2022

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: 08/02/2022
• Initial Date FDA Received: 08/29/2022
• Supplement Dates Manufacturer Received: 09/09/2022
• Supplement Dates FDA Received: 09/23/2022
• 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: NON-OLYMPUS LASER PULSE ENERGY; NON-OLYMPUS SHEATH AND BASKET
• Patient Outcome(s): Other