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

Model Number CYF-VHA

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

Patient Problems Fever (1858); Unspecified Infection (1930)

Event Date 05/21/2020

Event Type  Injury  

Manufacturer Narrative

The subject device has not returned to olympus medical systems corp. (omsc) for evaluation yet. There were no further details provided. If significant additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp. (omsc) was informed that the user facility found three patients were infected with unspecified microbes on (b)(6) 2020. The three patients underwent endoscopic procedures using cyf-vha on (b)(6) 2020. The patients' outcome is reportedly as follows. First patient: fever. Second patient: fever and hospitalization. Third patient: unknown. The cyf-vha had been reprocessed with an olympus automated endoscope reprocessor model oer-s using peracetic acid. The concentration of disinfectant of the oer-s was effective. The user wipes the cyf-vha with a sterile cloth after automated reprocessing cycle and stores the device in the basin of the oer-s until next procedure. Olympus is submitting 3 medwatch reports for the cyf-vha. This is the 1st of the 3 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 10183026
• MDR Text Key: 201048926
• Report Number: 8010047-2020-03568
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (Y/N): N
• Reporter Country Code: JA
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: USER FACILITY

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 09/15/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 06/23/2020
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: CYF-VHA
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 08/17/2020
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 11/07/2011
• 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: 06/23/2020 Patient Sequence Number: 1