MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS LUCERA BRONCHOVIDEOSCOPE

Model Number BF-1T260

Device Problem Device Reprocessing Problem (1091)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, the user¿s report was confirmed.Residual foreign material was found coming out of the tubing and compromising the reprocessing attempts.As noted, the presence of this foreign material is indicative of insufficient reprocessing.Additionally, the adhesive on the distal end was chipped and had foreign objects present.The forceps channel port was found dirty.Due to the elongation of the angle wire, the bending angle was out of specification.The connecting tube was also found dented.If additional information becomes available following the device evaluation, a supplemental report will be filed.

Event Description

The customer originally returned his olympus evis lucera bronchovideoscope as he was experiencing difficulties inserting/removing the cleaning brush during reprocessing.There was no patient involvement during this event.During the device evaluation, it was discovered that the subject device had undergone insufficient reprocessing as foreign material was found in the insertion tube.This report is being submitted to capture the insufficient reprocessing confirmed during the device evaluation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to h10 of the initial report with the information inadvertently left off.The following information was inadvertently left off of the initial report: the device was not cleaned, disinfected, and sterilized prior to sending back to olympus.It is not known about when the foreign material adhered to the endoscope.Precleaning after clinical use was either delayed (length of delay unknown) or not implemented.During manual cleaning, the brush became stuck and could not be removed.As a result, the endoscope was not immersed in detergent solution and distal end not wiped/brushed.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 information obtained on the foreign material could not be specified.It is likely that the obtained information on the foreign material might have remained since the reprocessing has not correctly been implemented in line with the ifu.The event can be detected/prevented by following the instructions for use which state: inspect the external surface of the entire insertion tube including the bending section and the distal end for dents, bulges, swelling, peeling, scratching, holes, sagging, transformation, bends, adhesion of foreign body, dropout of parts, any protruding objects or other irregularities.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA BRONCHOVIDEOSCOPE
• Type of Device: BRONCHOVIDEOSCOPE
• 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: 16495289
• MDR Text Key: 310794832
• Report Number: 9610595-2023-03848
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BF-1T260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2012
• 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