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

Model Number CYF-V2R

Device Problems Device Reprocessing Problem (1091); Microbial Contamination of Device (2303)

Patient Problem Unspecified Infection (1930)

Event Date 11/29/2023

Event Type  Injury  

Event Description

A user facility telephoned and provided photos of their reprocessing methods for visera cysto-nephro videoscope.Their reprocessing methods do not align with olympus reprocessing standards.Per the facility, the scopes were not being fully reprocessed.The brushing and leak test were not being performed and as a result they were having infections.Mdr's (b)(6) and (b)(6) represent the alleged multiple infections.This medwatch report is for the patient identifier (b)(6).

• Brand Name: VISERA CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• MDR Report Key: 18400419
• MDR Text Key: 331417373
• Report Number: 2429304-2023-00416
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339523
• UDI-Public: 04953170339523
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/29/2023,12/27/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-V2R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/29/2023
• Event Location: Hospital
• Date Report to Manufacturer: 11/29/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/27/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other