MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES CYSTONEPHROFIBERSCOPE

Model Number CYF-5

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

Patient Problem Urinary Tract Infection (2120)

Event Type  Injury  

Event Description

The customer reported that two patients may have developed a urinary tract infection (uti) from the device and requested a copy of the reprocessing instructions for the subject device to ensure that they are reprocessing the scopes correctly.No further information provided.The user facility did not provide a specific serial number for the device in question; therefore, it is unknown whether the subject device has been returned to olympus for service or not.Olympus contacted the user facility multiple times to obtain additional information regarding the reported event but to no avail.As part of our investigation into this report, olympus offered an on-site visit by an olympus endoscopy support specialist (ess) but the user facility declined the offer.No conclusion can be drawn at this time due to insufficient information provided by the user facility.This report will be supplemented when new information becomes available.This mdr is being submitted retrospectively as part of a remediation effort related to recent system and process changes.A capa has been opened to manage the actions related to remediation of this issue and any required mdr reporting.1 of 2 reports, this is related to patient identifier# (b)(4).

• Brand Name: OES CYSTONEPHROFIBERSCOPE
• Type of Device: CYSTONEPHROFIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11036198
• MDR Text Key: 222316288
• Report Number: 2951238-2020-00526
• 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: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/29/2020,12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CYF-5
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/29/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other