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

Model Number ENF-V2

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus for evaluation.During the evaluation, it was found that there was a crack in the bending section cover glue at the distal end side of the subject device.The bending section cover glue was also noted to be peeling.The scope passed the leak test.The scope was repaired and returned to the user facility.In addition, a review of the scope's instrument history records was reviewed and indicated the scope was purchased on april 16, 2016 with no service records.The exact cause could not be conclusively determined, however, the instruction manual provides the following warnings: do not twist or bend the bending section with your hands.Equipment damage may result.Do not squeeze the bending section forcefully.The covering of the bending section may stretch or break, and it may cause water leaks.As a preventive measure, the instruction manual for use states before each case to prepare and inspect the scope such as inspecting the covering of the bending section for sagging, swelling, cuts, holes or other irregularities.

Event Description

Olympus was informed that during the nasal examinations, epistaxis (nose bleeds) occured when the scope was withdrawn from the nasal cavity on 4-5 different patients.It was reported that the distal tip of the scope was described as flared or a bubble in the rubber about 2mm from the distal end.The nose bleeds were reportedly mild and did not last long.There was no treatment required as the nose bleeds subsided with pressure to the patients nose.The intended procedures were completed using the same scope.No patient injuries were reported.In addition, it is unknown if the scope was inspected prior to the procedures.1 of 5 patients.

• Brand Name: VISERA 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: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 8528707
• MDR Text Key: 142484926
• Report Number: 2951238-2019-00747
• Device Sequence Number: 1
• Product Code: EOB
• UDI-Device Identifier: 04953170291029
• UDI-Public: 04953170291029
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/18/2019

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
• Device Operator: Health Professional
• Device Model Number: ENF-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/20/2019
• Initial Date FDA Received: 04/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1