MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. RHINO-LARYNGO VIDEOSCOPE

Model Number ENF-VH

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 11/07/2022

Event Type  malfunction  

Manufacturer Narrative

The endoscope specialist (ess) recommended enf scope be sent in for olympus repair due to clicking noise.The ess also offered in-person reprocessing training with staff members.The ess also ran repair history report and facility has had no repairs through olympus (ran repair history for 2 years, scopes were purchased in march of 2022).The device was not returned.The investigation is ongoing.A supplemental will be submitted on completion of investigation or if any additional information is available.

Event Description

The customer reported to the endoscope specialist (ess) during a site visit that there was clicking noise coming from the control body of the rhino-laryngo videoscope.The customer had questions regarding the steris resert (high level disinfectant) they were using and potential other high level disinfectants.The customer questioned if steris resert was the root cause of the problem.The user had the same issue in the past and scopes were sent in for repair.The ess recommended the user to verify the compatibility of the steris resert with olympus devices.The customer also noted that some of the reprocessing steps recommended as per olympus instructions for use (ifu) were not being followed.No bedside precleaning was performed.Leakage test was done with handheld leakage tester and not in water; and it was done occasionally.The scope was not completely immersed in enzymatic water for manual cleaning and the scope was not completely immersed in high level disinfectant or rinse water after high level disinfection.The scope was not hung in drying cabinet between procedures.There was no patient involvement.

• Brand Name: RHINO-LARYNGO VIDEOSCOPE
• Type of Device: RHINO-LARYNGO VIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15914874
• MDR Text Key: 308032041
• Report Number: 3002808148-2022-04850
• Device Sequence Number: 1
• Product Code: EOB
• UDI-Device Identifier: 04953170411403
• UDI-Public: 04953170411403
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENF-VH
• Device Catalogue Number: N6006840
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2021
• 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