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

Model Number BF-1T260

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 03/23/2023

Event Type  malfunction  

Manufacturer Narrative

E1 complete state/province: (b)(6) this device was returned for evaluation.During the inspection, it was found that the adhesive at the bending cover was aging and fell off, the insertion section had serious scratches and the protector was aging.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

The customer reported to olympus that the bending cover of this evis lucera bronchovideoscope has come off during inspection before use for an unknown diagnostic procedure.The procedure was delayed for thirty (30) minutes, increasing patient's waiting time.The patient, as reported, was not under sedation when issue was found.The procedure was completed with a similar device.There were no reports of patient or user harm associated with this event.

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, it is likely the phenomenon is due to the bending section cover glue deteriorated caused by physical stress and/or chemical stress and fell off by use in deteriorated condition.However, the root cause of the phenomenon could not be specified.The event can be detected and prevented by following the instructions for use which state: ¿inspect the external surface of the entire insertion section including the bending section and the distal end for dents, bulges, swelling, scratches, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities.¿ "do not strike, hit, or drop the distal end, insertion tube, bending section, control section, universal cord, or endoscope connector of the endoscope.Also, do not bend, pull, or twist the distal end, insertion tube, bending section, control section, universal cord, or endoscope connector of the endoscope with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient." "olympus endoscopic equipment is compatible with several methods of reprocessing.However, certain components and accessories are not compatible with some methods, which can cause equipment damage.For appropriate reprocessing methods, refer to table 2.1 below, the recommendations of your infection control committee, and all national and local hospital guidelines and policies." 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: 16792292
• MDR Text Key: 314166493
• Report Number: 9610595-2023-06533
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2023
• 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: 03/27/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2012
• 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