MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA BRONCHOFIBERVIDEOSCOPE

Model Number BF-MP160F

Device Problems Device Reprocessing Problem (1091); Device Contamination with Chemical or Other Material (2944)

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

Event Date 02/16/2023

Event Type  malfunction  

Event Description

An olympus field service engineer reported on behalf of a customer, the evis exera bronchofiberscope had black dots coming in image.The event was found during maintenance.There was no report of patient harm.During incoming inspection, the distal end was dirty, bending section cover was dirty, and the light guide lens had foreign objects, due to insufficient reprocessing.This medwatch is being submitted to capture the reportable malfunctions found during evaluation.

Manufacturer Narrative

The subject device was returned to olympus for evaluation.During inspection and testing, the allegation was confirmed.Image bundle had a stain.In addition to evaluation in b5, due to deformation of electrical connector; water tightness was lost.The image guide bundle had significant breakages,the forceps channel port had a dent.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.The foreign material could not be identified.A definitive root cause for the material remaining in the device was not established.Foreign material may not have been removed due to improper reprocessing caused by leakage in the device.Reprocessing of subject device the customer is trained per instructions for use (ifu).Typically, pre-cleaning steps are performed without any delays but there was a possibility that sufficient brushing could not be performed.The subject device was not correctly reprocessed at the time of pickup due to being in the workshop for inspection.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported malfunction.The dhr confirmed that the subject device was shipped in accordance with the specifications.Olympus will continue to monitor field performance for this device.

Event Description

Additional information was provided regarding this event.The event occurred during maintenance.There was no procedure or patient involvement.

• Brand Name: EVIS EXERA BRONCHOFIBERVIDEOSCOPE
• Type of Device: BRONCHOFIBERVIDEOSCOPE
• 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: 16738749
• MDR Text Key: 313358939
• Report Number: 9610595-2023-06113
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K033225
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BF-MP160F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2012
• 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