MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. VISERA RHINO-LARYNGOVIDEOSCOPE; RHINO-LARYNGO VIDEOSCOPE

Model Number	ENF-V
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus that the visera rhino-laryngovideoscope had a crack in the coating of the sheath.The issue was observed during preparation for use on a diagnostic procedure.No reports of patient harm were associated with this event.The device was returned to olympus for a device evaluation and found that the coating fell off due to the tear of the insertion part.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
Additional Manufacturer Narrative
The device was returned to olympus for a device evaluation and the customer¿s allegation was confirmed.The coating fell off due to the tear of the insertion part.It is likely that the coating fell off due to aging deterioration, the stress of use, or external factors and handling that led to the event.A manufacturing and quality control review was performed for the affected serial number without showing any non-conformities or deviations regarding the described issues.There is a warning as below in the instruction manual ¿chapter 3 preparation and inspection 3.2 preparation and inspection of the endoscope".Inspection of the endoscope 2.Visually inspect the boot and the insertion tube near the boot for bends, twists or other irregularities.3.Visually inspect the surface of the insertion tube for dents, bulges, swelling, peeling or other irregularities.4.Carefully run your fingertips over the entire length of the insertion tube.Inspect for any protruding objects or other irregularities (see figure 3.2).Olympus will continue to monitor the field performance of this device.

• Brand Name: VISERA RHINO-LARYNGOVIDEOSCOPE
• Common Device Name: RHINO-LARYNGO VIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17481904
• Report Number: 9610595-2023-11331
• Device Sequence Number: 17888226
• Product Code: EOB
• UDI-Device Identifier: 20613994394600
• UDI-Public: 20613994394600
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/08/2023

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: 07/09/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2005
• 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