MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. RHINO-LARYNGO FIBERSCOPE; RHINO-LARYNGOFIBERSCOPE

Model Number	ENF-P4
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred during reprocessing of the device.There was no patient involvement.The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, the distal portion of the plastic cover was detached.The bending section cover (a-rubber) was missing and the image was foggy.Additionally, the distal end of the bending section separated.The image was foggy, and there were buckles noted on the insertion tube.Furthermore, the scope connector had a loose eto valve, and light guide prong cover glass.A supplemental report will be submitted when the investigation is finalized and/or if additional information should become available.
Event or Problem Description
It was reported the distal end of the rhino-laryngo fiberscope separated during reprocessing.
Additional Manufacturer Narrative
The following fields were updated: g4, g7, h2, h4, h6, h10.This supplemental report is being submitted to provide the results of the manufacturer¿s investigation.A review of the device history record (dhr), and a review of the instructions for use (ifu) were conducted during this investigation.The ifu contains the following statements: ¿before each case, prepare and inspect this instrument as instructed below.Inspect other equipment that are used with this instrument as instructed in their respective instruction manuals.Should the slightest irregularity be suspected, do not use this instrument and see chapter 5, ¿troubleshooting¿.If the irregularity is still suspected after consulting chapter 5, contact olympus.Damage or irregularity may compromise patient or user safety and may result in more-severe equipment damage.¿ the review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.A definitive root cause could not be determined.However, investigation has concluded that the event likely occurred as a result of the age of the device or there is a possibility that the a-rubber fell off because external force was applied to the a-rubber and it was torn.Olympus will continue to monitor the field performance of this device.

• Brand Name: RHINO-LARYNGO FIBERSCOPE
• Common Device Name: RHINO-LARYNGOFIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10927942
• Report Number: 8010047-2020-09662
• Device Sequence Number: 16954415
• Product Code: EOB
• UDI-Device Identifier: 04953170411069
• UDI-Public: 04953170411069
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K011869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2021

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-P4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 02/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1