MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. RHINO-LARYNGO VIDEOSCOPE; FLEXIBLE VIDEO LARYNGOSCOPE

Model Number ENF-V3

Device Problem Device Reprocessing Problem (1091)

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

Event Date 11/09/2022

Event Type  malfunction  

Manufacturer Narrative

The following patient identifiers are related to each other: (b)(6) (model number enf-vh - rhino-laryngo videoscope: serial number (b)(4)), (b)(6) (model enf-v3 - rhino-laryngo videoscope : serial number (b)(4)), (b)(6) - model gif-n180 - evis exera ii gastrointestinal videoscope : serial number (b)(4)) and (b)(6) (model oer-elite - endoscope reprocessor).When speaking to the olympus endoscopy support specialist (ess), the reprocessing technicians explained this was occurring because the scopes were just ¿expired¿ scopes that needed to rerun and were ¿clean.¿ it was further explained that at this time, there was not a way to scan enf scopes into the elite for the reprocessor to run, which was why the enf scopes were with the gif scope.The endoscopy support specialist (ess) instructed the reprocessing technicians that it was against the elite¿s instructions for use (ifu) to reprocess three (3) scopes at once.Additionally, enf scopes are not compatible to run in the oer-elite with gif scopes.A quote was made for the radio-frequency identification (rfid) tags to be made for the scopes to run in the elite by themselves.Ess relayed this information to the management at the user facility.The ess ensured the scopes that were placed in the elite were re-high-level disinfected (hld) properly.The customer has a back up plan until the rfid tags come in to hld soak in cidex.The investigation is ongoing and follow up with the user facility is currently being performed.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 endoscopy support specialist (ess) reported that while performing reprocessing training on the tjf-q190v scope, the ess observed that the customer site was washing three (3) scopes (enf-vh, enf-v3 and gif-n180) in the oer-elite instead of the recommended two (2).There were no reports of patient harm associated with this event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see updates to h4, h6 and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was not returned for evaluation.Based on the results of the investigation, the root cause of the device being incorrectly reprocessed by the customer was unable to be identified.The following is included in the instructions for use: ¿oer-elite operation manual.6.5 basic operation for reprocessing.Chapter 6 reprocessing operations.Channel monitoring.This re-processor has the channel monitoring function, which monitors the fluid flow of each endoscope channel during the reprocessing process and checks clogging of the endoscope¿s suction channel (channel blockage monitoring) and the connection status of the connecting tubes (channel connectivity monitoring).The channel monitoring function can detect the following status during the reprocessing process.Channel blockage monitoring.Complete blocking of the endoscope¿s suction channel (stoppage by foreign object or buckling of suction channel).¿ olympus will continue to monitor field performance for this device.

• Brand Name: RHINO-LARYNGO VIDEOSCOPE
• Type of Device: FLEXIBLE VIDEO LARYNGOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15952448
• MDR Text Key: 308078308
• Report Number: 3002808148-2022-05068
• Device Sequence Number: 1
• Product Code: EOB
• UDI-Device Identifier: 04953170411366
• UDI-Public: 04953170411366
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/20/2021
• 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: ENF-VH SERIAL NUMBER (B)(6).; GIF-N180 SERIAL NUMBER (B)(6).; OER-ELITE.