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

Model Number	ENF-T3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device in this report has not been returned to olympus medical systems corp.(omsc) for evaluation.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 or Problem Description
Olympus medical systems corp.(omsc) was informed that during a polypectomy of the left vocal cord using the subject device, the patient had a nose bleeding because the folds and protrusion of the subject device such as the lens damaged the patient's nasal mucosa.The patient complained of nasal pain and discomfort after the procedure.There was no report of additional treatment was performed for the patient.There was no report of further patient injury with the event.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information.Olympus followed up with the user facility and received the additional information for the serial number of the subject device.Therefore, the section d4 "serial number" has been changed to (b)(6) from unknown.Olympus trading (shanghai) limited (osh) reviewed the service history of the subject device and confirmed that the device has never been returned to osh for repair.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined because the subject device was not returned omsc for evaluation.Deterioration of the device might have contributed to the reported event because the device is more than 6 years old with no repair history.

• Brand Name: RHINO-LARYNGOFIBERSCOPE
• 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: 9626653
• Report Number: 8010047-2020-01013
• Device Sequence Number: 2664427
• Product Code: EOB
• UDI-Device Identifier: 04953170050992
• UDI-Public: 04953170050992
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K011869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,user facilit
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2020

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?: No
• Operator of Device: No Information
• Device Model Number: ENF-T3
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 01/24/2020
• Supplement Report FDA Received Date: 02/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR