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

Model Number ENF-V3

Device Problem Problem with Sterilization (1596)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.During the evaluation, a small leak around the eto pin was found.A light scratch was found on pcb but no leak.No other issues were found during the inspection.If additional information is provided a supplemental report will be filed.

Event Description

A user facility reported that a laryngo-videoscope will not pass the sterrad machine sterilization process.No patient involvement or injuries were reported.No additional information has been obtained.

Manufacturer Narrative

The user facility provided additional information regarding the reported event.There was only one scope involved in the event.The user facility reported that the device is cleaned immediately after a procedure.The endoscope channel is not being brushed during the manual cleaning.All their personnel in charge of reprocessing the device are properly trained.The device was working properly prior to the reported failure.Instructions for use (ifu) states: ¿before reprocessing, thoroughly review this manual and the manuals of the reprocessing equipment and chemicals that will be used for reprocessing.Reprocess all the devices as instructed.¿ the investigation has been completed.A device history record (dhr) was performed and found no non-conformances that would cause the reported malfunction.All records indicate that the device was manufactured in accordance with all applicable procedures.

• Brand Name: 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
• MDR Report Key: 10542436
• MDR Text Key: 207294260
• Report Number: 8010047-2020-06586
• Device Sequence Number: 1
• Product Code: EOB
• UDI-Device Identifier: 04953170411366
• UDI-Public: 04953170411366
• Combination Product (y/n): N
• PMA/PMN Number: K061313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENF-V3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1