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

Model Number BF-H190

Device Problem Device Reprocessing Problem (1091)

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

Event Date 02/16/2024

Event Type  malfunction  

Manufacturer Narrative

The device was not returned; however, the customer requested an endoscope specialist on site for training.Also, a reprocessing manual was emailed to the customer regarding methods/details of reprocessing the device.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported, the bronchovideoscope was not cleaned after use, but was found in a sink in the facility soiled utility room soaking in water.There was no patient involvement.

• Brand Name: EVIS EXERA III 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18829242
• MDR Text Key: 337073255
• Report Number: 9610595-2024-04479
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04953170335174
• UDI-Public: 04953170335174
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BF-H190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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