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

Model Number ENF-V3

Device Problems Device Reprocessing Problem (1091); Failure to Clean Adequately (4048)

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

Event Date 06/14/2022

Event Type  malfunction  

Manufacturer Narrative

It was reported that an olympus field service engineer (fse) spoke with the facility and impressed the importance of properly reprocessing the subject device using the indicated methods from the instructions for use (ifu).The facility state that they would consider improving their operations in the future.The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus, the endoscope reprocessor displayed error e99 during reprocessing of the olympus rhino-laryngo videoscope.It was suspected that the error occurred because the number of oer-4 device used at the facility has increased sharply recently and acecide was replaced once a week.In addition, it was indicated, the acecide concentration check was not performed, and even after e99 occurred, the scope was reprocessed and used for the next patient.This medical device report (mdr) is being submitted to capture the reportable malfunction for the insufficient or incorrect reprocessing of the scope which was used in a procedure.There was no harm or user injury reported due to the event.This report is related to patient identifier: ((b)(6)).

Manufacturer Narrative

A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported event.The dhr confirmed that the subject device was shipped in accordance with the specifications.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The investigation confirmed the reported e99 error code.The investigation also confirmed that the subject device (olympus rhino-laryngo videoscope) was incorrectly/insufficiently reprocessed.The reprocessing was performed without checking the concentration of acecide.The reported event occurred because the end-user did not apply the reprocessing instructions specified in the instructions for use (ifu).Olympus will continue to monitor field performance for this device.

• 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: 15030611
• MDR Text Key: 304706763
• Report Number: 3002808148-2022-00006
• Device Sequence Number: 1
• Product Code: EOB
• UDI-Device Identifier: 04953170411366
• UDI-Public: 04953170411366
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K061313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENF-V3
• Device Catalogue Number: N6006640
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2021
• 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
• Treatment: OER-4