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

Model Number	ENF-V
Medical Device Problem Codes	Break (1069); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the reported issue was confirmed.The bending section cover was broken.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The olympus representative reported on behalf of the customer, the bending part was cut on the visera rhino-laryngovideoscope.The issue was found during preparation for use for a diagnostic procedure.The intended procedure was completed with the same device and no surgical delay.No patient harm reported.During the evaluation of the device, it was noted the angle could not be controlled and could not be straightened due to breakage of the angle wire.Additionally noted were scratches on the objective lens and a broken bending section cover.This report is to capture the reportable malfunctions of the angle could not be controlled and could not be straightened due to breakage of the angle wire, scratches on the objective lens, and a broken bending section cover noted at estimation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to correct date device returned.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 15 years since the subject device was manufactured.Based on the results of the investigation, the malfunctions (angle could not be controlled, bending section adhesive was broken with exposed metal, and scratches on the objective lens) were likely caused by excessive physical stress applied to the subject device.The event can be detected/prevented by following the instructions for use which state: "important information ¿ please read before use: warnings and cautions: do not apply shock to the distal end of the insertion tube, particularly the objective lens surface at the distal end.Visual abnormalities may result.Do not twist or bend the bending section with your hands.Equipment damage may result." olympus will continue to monitor field performance for this device.

• Brand Name: VISERA RHINO-LARYNGOVIDEOSCOPE
• Common Device Name: 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: 13414546
• Report Number: 8010047-2022-02216
• Device Sequence Number: 14760668
• Product Code: EOB
• UDI-Device Identifier: 04953170399640
• UDI-Public: 04953170399640
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2022

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-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2022
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 02/01/2022
• Supplement Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2004
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown