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

Model Number BF-1T150

Device Problem Defective Component (2292)

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

Event Date 09/25/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned and evaluated, and the customer¿s allegation was not confirmed due to the deterioration of the charged-coupled device unit.The additional evaluation findings are as follows: the light guide lens and plastic distal end cover were missing.The plastic distal end cover was burned and missing.The control unit and universal cord had scratches.Due to damage to the charged coupled device unit, the image had shadows.Due to the wear of the angle wire, the bending angle in the up direction did not meet the standard value.There are dents and scratches in the insertion section.The connecting tube had a dent.The adhesive on the bending section cover was detached.Due to the wear of the angle wire, the bending angle in the down direction did not meet the standard value.The customer did not reprocess the scope before sending the device to olympus for repair because the damaged bending section (bending section cover and plastic distal end cover) would not allow for adequate reprocessing.The customer confirmed following the reprocessing steps as per the information for use (ifu).The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus that the bronchovideoscope had a depression in the insertion tube and the plastic distal end cover was damaged.The issue occurred during the procedure, and the therapeutic procedure (intubation) was postponed.Later, a similar non-olympus device was used to intubate.There were no reports of patient harm.The device was returned and evaluated; the plastic distal end cover and light guide lens were missing, and foreign objects were found in the distal end.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final 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 could not be identified although it can be presumed that it was due to physical stress.The event can be detected/prevented by handling the device in accordance with the following instructions for use: -inspection of the endoscope.Olympus will continue to monitor field performance for this device.

• Brand Name: 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: 18043887
• MDR Text Key: 328226164
• Report Number: 9610595-2023-16253
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04953170308185
• UDI-Public: 04953170308185
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K023984
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BF-1T150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2019
• 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