MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. VISERA CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-V2

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

Patient Problems Bacterial Infection (1735); Cardiac Arrest (1762); Hematoma (1884); Hemorrhage/Bleeding (1888); Pleural Effusion (2010); Renal Failure (2041); Rupture (2208); Pseudoaneurysm (2605); Renal Impairment (4499)

Event Date 09/10/2021

Event Type  Injury  

Manufacturer Narrative

Since the literature described "18fr flexible cystoscope", olympus selected "cyf-v2" as a representative product.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 literature titled "iatrogenic renal rupture in conduitoscopy - a diagnostic trauma." this case report study was aimed to determine the iatrogenic renal rupture in conduitoscopy.The case was complicated by a significant renal rupture causing a right renal interpolar artery pseudoaneurysm, and resulted in a prolonged hospital stay with multiple post-operative complications.Two polyps were identified and biopsied subsequent draining cultures were positive for bacteroides fragilis.In follow-up imaging, with repeat drain cultures positive for a resistant escherichia coli and enterococcus faecalis.The patient developed fevers and flank pain.This case serves as a warning that even simple conduitoscopy could result in life threatening bleeding and demonstrates the need for caution and risk management with diagnostic procedures.It was hoped that by individual patient assessment for specific risk factors, and by harm reduction methods, such complications may be avoided in the future.Type of adverse events/ 1 patient: renal capsule rupture, perinephric hemorrhage/hematoma, renal cortex injury (multifocal disruption), arterial injury with pseudoaneurysm formation, cardiac arrest, renal function deteriorated, hemodialysis, pleural effusion (reactionary), infection bacteroides fragilis, escherichia coli and enterococcus faecalis).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.This supplemental report includes information added to g2.Olympus will continue to monitor field performance for this device.

• Brand Name: VISERA CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• 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: 15458774
• MDR Text Key: 300341872
• Report Number: 9610595-2022-02000
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339431
• UDI-Public: 04953170339431
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CYF-V2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/07/2022
• 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): Required Intervention; Hospitalization; Other; Life Threatening
• Patient Age: 77 YR
• Patient Sex: Female