MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. VISERA TRACHEAL INTUBATION VIDEOSCOPE

Model Number LF-V

Device Problem Device Reprocessing Problem (1091)

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

Event Date 03/29/2023

Event Type  malfunction  

Event Description

It was reported to olympus, that during facility observation.The endoscopy support specialist noted, the customer reported, that they did not use the suction cleaning adapter (maj-1077) during manual high level disinfection cleaning.They just use a syringe to flush the ports, during all the steps of manual high-level disinfection of the visera tracheal intubation videoscope.This record is being submitted to capture the device being reprocessed with a different procedure from the instruction manual.There were no reports of patient harm or impact associated with this event.

Manufacturer Narrative

The device was not returned to olympus for evaluation.The facility was not following the instruction for use (ifu) steps for reprocessing.The customer was informed, that according to the ifu, in order to perform the manual high level disinfection process, the user would need that suction cleaning adapter tubing (maj-1077).The model was reviewed during the in-service.In-service recommended, that the customer follow all olympus reprocessing procedures as documented in the reprocessing manual.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the incorrect cleaning was failure to follow instructions.Olympus will continue to monitor field performance for this device.

• Brand Name: VISERA TRACHEAL INTUBATION VIDEOSCOPE
• Type of Device: TRACHEAL INTUBATION VIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16831624
• MDR Text Key: 314172803
• Report Number: 9610595-2023-06860
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04953170340246
• UDI-Public: 04953170340246
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221631
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LF-V
• Device Catalogue Number: N4500330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/29/2023
• Initial Date FDA Received: 04/28/2023
• Supplement Dates Manufacturer Received: 05/26/2023
• Supplement Dates FDA Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2013
• 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