MAUDE Adverse Event Report: MASAHARU.HIROSE@OLYMPUS.COM CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-VH

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Event Description

The customer reported to olympus two patients had infections after unspecified cystoscopy procedures involving the subject device.The nurse stated she is unsure if the infection came from the device.She is unsure what device was used and could have been cv-170 serial number (b)(4).The nurse requested a reprocessing in-service.Patient 1 had a cystoscopy (b)(6) 2022 with a positive culture dated (b)(6) 2022 with e.Faecalis.Patient 1 treated with oral cipro and was not hospitalized.The patient's next visit is not until his annual appointment in (b)(6) 2023.Patient 2 had a cystoscope on (b)(6) 2022 with a positive culture on (b)(6) 2022 with e.Cloacae.The nurse also noted, on (b)(6) 2022, the patient's cystoscope was cancelled due to hematuria, leukocytes and blood present in the urinalysis.No treatment was provided at that time.The cystoscope was rescheduled but the patient was hospitalized before the next appointment because of hematuria and before his culture.The patient was discharged with an indwelling catheter for two weeks and the e.Cloacae culture was identified post-hospitalization.It's unclear when the patient had a procedure involving the subject device.This event includes 2 reports: (b)(6): patient 1.(b)(6) : patient 2.

• Brand Name: CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): MASAHARU.HIROSE@OLYMPUS.COM; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• MDR Report Key: 15814308
• MDR Text Key: 303901977
• Report Number: 2429304-2022-00128
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170310461
• UDI-Public: 04953170310461
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/01/2022,11/17/2022

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-VH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/01/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/01/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/17/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male