MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. OES CYSTONEPHROFIBERSCOPE

Model Number CYF-5

Device Problem Failure to Clean Adequately (4048)

Patient Problems Fever (1858); Nausea (1970); Pain (1994); Urinary Tract Infection (2120)

Event Type  Injury  

Event Description

The customer reported to olympus that four patients had urinary tract infections post cystoscopy cases using cystonephrofiberscope.The provider was concerned that the scopes were not being reprocessed correctly before patient use.As reported, the customer had been leaving scopes overnight in a container before reprocessing.A leak had been identified in one scope that was used on three out of the four infected patients.The scopes have not been tested for microbial contamination.The patients had body fluid cultured and presented symptoms of fever, nausea, and pain.There were no reports of further patient or user harm associated with this event.Patient identifiers: (b)(6) (patient infection); (b)(6) (leaking scope and patient infection); (b)(6) (leaking scope and patient infection); (b)(6) (leaking scope and patient infection).This report is for (b)(6).

• Brand Name: OES CYSTONEPHROFIBERSCOPE
• Type of Device: CYSTONEPHROFIBERSCOPE
• 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: 17424101
• MDR Text Key: 320089065
• Report Number: 2429304-2023-00230
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339417
• UDI-Public: 04953170339417
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/12/2023,07/31/2023

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-5
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/12/2023
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 07/12/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/31/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other