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 Problem Unspecified Infection (1930)

Event Date 07/04/2019

Event Type  Injury  

Manufacturer Narrative

The subject device in this report has not been returned to olympus medical systems corp. (omsc) for evaluation because the user facility continues to use the subject device. The exact cause of the reported event could not be conclusively determined at this time. If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp. (omsc) was informed that a patient was infected with urosepsis after cystoscopy using the subject device. The patient underwent cystoscopy and transrectal ultrasound-guided prostate biopsy on (b)(6) 2019, and was discharged from the user facility on the day. The patient visited the user facility again on (b)(6) 2019, and treatment for urosepsis was commenced. After that, the patient was then transferred to another user facility and treated with intravenous antibiotics and oral antibiotics. The patient was discharged from this user facility several days later. Other detailed information such as the reprocessing method was not provided. The user facility continues to use the subject device because no other infection was reported. The user facility mentioned that they believe that the subject device was not the cause of the patient infection.

• 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: 8924937
• MDR Text Key: 155323298
• Report Number: 8010047-2019-03023
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (Y/N): N
• Reporter Country Code: UK
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/08/2019

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 08/23/2019
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: CYF-VH
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 09/13/2019
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 06/19/2018
• 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: 08/23/2019 Patient Sequence Number: 1