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

Model Number ENF-VT2

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

Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)

Event Date 11/17/2019

Event Type  Injury  

Manufacturer Narrative

The subject device in this report has not been returned to olympus medical systems corp.(omsc) for evaluation.There was no malfunction report of the subject device.Since the serial number of this device is unknown and omsc could not confirm the manufacturing history.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 unspecified diagnostic procedure, the patient complained of pain and discomfort by the mucosa bleeding.The user facility made the patient relaxed and then completed the procedure smoothly.There was no report of further patient injury with the event.There was no further information reported.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.On march 3rd, 2020, olympus followed up with the user facility and was informed that the event described in the initial report did not occur in fact.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 9816448
• MDR Text Key: 196310489
• Report Number: 8010047-2020-01745
• Device Sequence Number: 1
• Product Code: EOB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K061313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/26/2020

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
• Device Operator: No Information
• Device Model Number: ENF-VT2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/18/2020
• Initial Date FDA Received: 03/11/2020
• Supplement Dates Manufacturer Received: 03/03/2020
• Supplement Dates FDA Received: 03/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 43 YR