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

Model Number ENF-VH

Device Problem Device Reprocessing Problem (1091)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/17/2022

Event Type  malfunction  

Manufacturer Narrative

Olympus technical assistance center (tac) support spoke to the customer to discuss about the reported issue.The customer mentioned that the device was disinfected, wrapped, and stored in a asp sterrad sterilizer.The customer mentioned that the facility often disinfects scopes and wraps the devices before storing over the weekend.The rhino-laryngo videoscope was wrapped and placed in a sterilizer; however, it was not sterilized.Tac referenced the device operation manual and informed the customer about standard storage environment temperatures.The customer declined to send in the device for evaluation and repair.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time, however, if additional information becomes available, this report will be supplemented accordingly.

Event Description

The customer reported incorrect reprocessing with the rhino-laryngo videoscope.The event occurred during routine check and there was no patient harm or user injury reported due to the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 4 years since the subject device was manufactured.Based on the results of the investigation, it¿s probable the reported event (incorrect reprocessing) was due to human error.However, the root cause of this event was unable to be identified.The following is included in the reprocessing manual: ¿chapter - storage and disposal.Precaution of storage and disposal.[caution].Store the endoscope and accessories in an endoscope storage cabinet which also protects the equipment from physical damage.To prevent damage, do not store the endoscope and/or accessories in direct sunlight, at high temperatures, in high humidity, or exposed to x-rays, ultraviolet rays, or ozone.To prevent damage, do not store the endoscope and/or accessories with chemicals or in a gas-generating area.¿ olympus will continue to monitor field performance for this device.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 15015601
• MDR Text Key: 304597501
• Report Number: 8010047-2022-11925
• Device Sequence Number: 1
• Product Code: EOB
• UDI-Device Identifier: 04953170310447
• UDI-Public: 04953170310447
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENF-VH
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1