MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. RHINO-LARYNGO FIBERSCOPE; RHINO-LARYNGOFIBERSCOPE

Model Number	ENF-XP
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus medical that the rhino-laryngo fiberscope failed the leak test due to the distal tip peeling off.No adverse effects to patient reported.
Additional Manufacturer Narrative
The device was returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Updated fields: h6 and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been more than 2 years since the subject device was manufactured.Based on the results of the investigation, excessive stress was placed on the device by the user during reprocessing/maintenance which resulted in damage.The event can be detected and prevented in accordance with the following instructions for use: operation manual chapter 3 preparation and inspection in addition, the following non-reportable malfunctions were found during the device evaluation: the bending section cover (a-rubber) was torn.The image guide (ig) had excessive damage.The insertion tube was dented.Olympus will continue to monitor field performance for this device.

• Brand Name: RHINO-LARYNGO FIBERSCOPE
• Common Device Name: RHINO-LARYNGOFIBERSCOPE
• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17417281
• Report Number: 9610595-2023-10807
• Device Sequence Number: 7135040
• Product Code: EOB
• UDI-Device Identifier: 04953170059018
• UDI-Public: 04953170059018
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K221660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2023

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-XP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2023
• Supplement Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 07/28/2023
• Supplement Report FDA Received Date: 09/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2021
• 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