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

Model Number CYF-VH

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

Patient Problems Unspecified Infection (1930); Sepsis (2067); Urinary Tract Infection (2120)

Event Date 12/16/2019

Event Type  Injury  

Event Description

The service center was informed of a reported patient infection as the infection prevention and control manager stated the facility was investigating two patients who acquired urinary tract infections and blood stream infections with the same organism post cysto procedure for stent removal.Different scopes were used for each procedure.The facility has observed the procedure in the clinic setting and did not observe any practice or infection control concerns.The scopes have been sent to the manufacturer's service center for evaluation of the scopes to ensure integrity.As part of our investigation, an olympus endoscopy support specialist (ess) was requested to be dispatched to the user facility to observe the facilities reprocessing practice and to provide a reprocessing training.To date, the ess visit has not been finalized.The scope was returned and was forwarded to an independent laboratory for microbial testing.If additional information becomes available, this report will be supplemented accordingly.This is for 1 of 2 reports.

• Brand Name: 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
• MDR Report Key: 9975518
• MDR Text Key: 188222678
• Report Number: 2951238-2020-00427
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411250
• UDI-Public: 04953170411250
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/20/2020,04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CYF-VH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/20/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 50