MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. RHINO-LARYNGO FIBERSCOPE; RHINO-LARYNGOFIBERSCOPE

Model Number	ENF-P4
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information for this event is not yet available.Device is not returned, as such a definitive root cause of the reported complaint cannot be determined at this time.Supplemental report(s) will be filed as the information becomes available.
Event or Problem Description
As reported for this event, the customer reported that a leak test is not done on the device.There is no reported harm to any patient.
Additional Manufacturer Narrative
Additional information has been received from the customer.This supplemental report is being submitted to provide this information.The customer now has the leak tester.There have been no patient infections or positive scope cultures related to this issue.
Additional Manufacturer Narrative
Additional information has been received for this event.This supplemental report is being submitted to provide this information.The customer only use the distal end of the device.As such, the customer has only been soaking and cleaning the device from the boot down with no leak test and wiping the rest of the scope down as they do not touch it without gloves on.However, the customer has bought a leak tester now and an in-service performed to educate the customer.In-service consisted of reprocessing training including proper endoscope handling, repair prevention, pre-cleaning, leak testing, manual cleaning and high level disinfection according to the olympus reprocessing manual.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The following sections were updated: d5, d8, e2, e3, g3, g6, h2, h4, h6, and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the legal manufacturer's investigation, due to human error, the facility did not initially have a leak tester and was not performing leak testing.

• Brand Name: RHINO-LARYNGO FIBERSCOPE
• Common Device Name: RHINO-LARYNGOFIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11335033
• Report Number: 8010047-2021-02697
• Device Sequence Number: 16377577
• Product Code: EOB
• UDI-Device Identifier: 04953170411069
• UDI-Public: 04953170411069
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K011869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ENF-P4
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 02/23/2021; 03/19/2021; 05/25/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 03/16/2021; 04/13/2021; 06/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1