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

Model Number ENF-VT2

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 10/21/2019

Event Type  Injury  

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 Description

Olympus medical systems corp.(omsc) was informed that during an electronic laryngoscopy, the patient had a nose bleeding because the bending section of the subject device could not be straightened and the distal end damaged the patient's nasal septum.The user facility conducted an unspecified hemostasis due to the large amount of bleeding.There was no report of further patient injury with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.On december 13th, 2019, olympus followed up with the user facility and received detailed information of the procedure where the event occurred as follows; the endoscopic image of the subject device disappeared when the bending section of the subject device was angulated.The user facility immediately stopped the procedure and removed the subject device from the patient when the endoscopic image of the subject device disappeared.The patient complained of discomfort during the procedure.The patient was discharged from the user facility after the procedure.The user facility continues to use the subject device.The subject device has been repaired by a third party company.It was reported that the serial number of the subject device is (b)(6), not (b)(6).Omsc reviewed the manufacturing history (dhr) of the 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 and the subject device was repaired by the third party company.

• Brand Name: RHINO-LARYNGO VIDEOSCOPE
• Type of Device: RHINO-LARYNGO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 9373797
• MDR Text Key: 184868314
• Report Number: 8010047-2019-04079
• Device Sequence Number: 1
• Product Code: EOB
• Combination Product (y/n): N
• PMA/PMN Number: K061313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ENF-VT2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other