MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-V2

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

Patient Problem Bacterial Infection (1735)

Event Date 10/18/2019

Event Type  Injury  

Manufacturer Narrative

The subject scope was not returned to the service center for evaluation. A review of the service history indicates the scope was purchased on (b)(6) 2013. There was one service event through an advance replacement program on december 24, 2018 for a scope that failed the leak test. The records indicate the user facility received a replacement scope but there is no record that shows the scope that failed the leak test was returned in exchange. As part of the investigation, an endoscopy service specialist (ess) visited the user facility and conducted an observation and an in-service regarding the reprocessing practice. The ess observed the staff was not using a leak tester, a channel brush, and incorrectly performing the high level disinfection process. The ess provided the user facility with reprocessing wall chart guides and trained the staff on how to properly perform pre-cleaning, leak testing, manual cleaning, and manual high level disinfection. The ess informed the user facility of the needed equipment such as leak tester and channel cleaning brush. Additionally, the user facility will plan on purchasing additional equipment in order to take into account the reprocessing time required for the scope to be patient ready. This reported event has been reported by the importer on mdr# 2951238-2019-01190.

Event Description

The manufacturer was informed that 24 hours after a cystoscopy procedure, the patient had a fever and needed to be hospitalized. The patient's urine culture indicated that the patient contracted pseudomonas aeruginosa >100,000 cfu/ml. The patient's urine culture on (b)(6) 2019 and prior to the procedure indicated that everything was normal. The facility utilizes aldahol for reprocessing and the aldahol's efficacy is tested daily.

• Brand Name: VISERA CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO 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: 9350372
• MDR Text Key: 181477914
• Report Number: 8010047-2019-04034
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,USER F

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/17/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 11/20/2019
• 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?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 02/27/2020
• Is The Reporter A Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 03/16/2020
• Was Device Evaluated By Manufacturer?: No
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient TREATMENT DATA

Date Received: 11/20/2019 Patient Sequence Number: 1