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

Model Number LF-TP

Device Problem Microbial Contamination of Device (2303)

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

Event Date 10/30/2023

Event Type  malfunction  

Event Description

The olympus representative (on behalf of the customer) reported to olympus, the tracheal intubation fiberscope tested positive for an unexpected contamination, and the users suspect tube scratches.The issue was found during reprocessing.The user did not report any contamination or any other serious deterioration in the state of health of any person, to which the scope could have been a contributory cause.

Manufacturer Narrative

The suspect device has been returned to olympus for evaluation and the physical device evaluation has been completed.The device was not sent out for additional microbiological testing.The issue was not confirmed, as the scope was not microbiologically tested by olympus.The device evaluation found that customer's allegation was confirmed, there were dents in the insertion tube.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.

Manufacturer Narrative

Correction to g2, health professional was inadvertently checked on the initial report.This report is being supplemented to provide additional information based on the customer provided cleaning disinfection and sterilization (cds) practices and the legal manufacturer's final investigation.The customer provided the following cds process information performed at the user facility: - pre-cleaning was performed immediately after the procedure - steps taken during precleaning: wipe the insertion part with enzyme solution gauze; enzyme solution; air, place it in the transfer vehicle transfer supply room - detergent used for precleaning was not provided - manual cleaning was not performed within an hour after the procedure - the device was presoaked in an enzyme solution - the endoscope channels were brushed during manual cleaning - the brush used was reusable manufactured by olympus - the disinfectant used is a complex chlorine disinfectant with an unknown manufacturer - the device was rinsed before manual disinfection - all channels were flushed and immersed in the disinfectant - the water quality was checked in the final rinse - an unknown model of xinhua cleaning and disinfection automatic endoscopic reprocessor (aer) was used - the detergent and disinfectant used with the aer was complex chlorine disinfectant - no issues were noted with the aer - the endoscope is dried with air - the endoscope is stored in a storage cabinet - there was no patient involvement - the device was quarantined and not used.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, a root cause could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: TRACHEAL INTUBATION FIBERSCOPE
• Type of Device: TRACHEAL INTUBATION FIBERSCOPE
• 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: 18095158
• MDR Text Key: 328060311
• Report Number: 9610595-2023-16724
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04953170136825
• UDI-Public: 04953170136825
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K981543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/11/2023

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-TP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/30/2023
• Initial Date FDA Received: 11/08/2023
• Supplement Dates Manufacturer Received: 11/29/2023
• Supplement Dates FDA Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2015
• 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