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

Model Number BF-1TQ180

Device Problems No Display/Image (1183); Entrapment of Device (1212); Detachment of Device or Device Component (2907)

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

Event Date 11/20/2023

Event Type  Injury  

Manufacturer Narrative

The device was returned and evaluated.In addition to the malfunction documented in b5, the additional evaluation findings are as follows: torn bending section rubber with a missing distal end, missing distal end plastic cover, bending section rubber partially missing, bending section rubber glue (non-olympus) missing from distal end, objective lens missing, light guide lens missing, no image due to missing distal end, bending section missing distal end, non-olympus insertion tube, and light guide tube (non-olympus) with excessive heavy buckle (2), the investigation is ongoing and follow up with the user facility is currently being performed.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, the bronchovideoscope distal tip was damaged.The issue was found during a procedure.The device was returned for evaluation.During the device evaluation, the following reportable malfunctions were found: defects of the distal end and the entire screen becomes black and shows no images.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Event Description

Olympus received further information that the distal tip was damaged during a diagnostic bronchoscopy in the middle of a surgical case for a mediastinal mass.The scope was requested for visualization.There were two other olympus bronchoscopes used prior to the incident with the bronchovideoscope.Due to scope changes, the procedure was delayed for less than 5 minutes with the patient under general anesthesia.The bronchoscopy portion was aborted after the bronchovideoscope became stuck in the endotracheal tube; however, the actual surgical case was completed.It was not known if the patient was impacted by the failure, but it was noted that endoscopic assistance was complete with removal of the damaged bronchoscope.The scope was inspected prior to use.Additional information was requested but no further information was received.

Manufacturer Narrative

This report is being supplemented to provide additional information and correction to the initial with information inadvertently left out.Please see updates to a2, a3, a4, b1, b2, b5, h1, and h6 and correction to g2 and h3.This report has been submitted by the importer under this mdr report number 2429304-2024-00018.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to provide a correction to the initial (d8).The device was returned to olympus for inspection, and the customer's complaint/reportable malfunction was confirmed.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 suggested event " the distal end was missing during procedure a therapeutic procedure.The procedure was aborted after extended less than 5 minutes for device changes." occurred due to the subject device was forcibly withdrawn while its distal end was being stuck in an endotracheal tube (ett); as a result, the distal end came off the bending section and was missing.The event can be prevented by following the instructions for use which state: -operation manual important information ¿ please read before use "never insert or withdraw the insertion section abruptly or with excessive force.Patient injury, bleeding, and/or perforation may result.".Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II 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: 18302337
• MDR Text Key: 330179446
• Report Number: 9610595-2023-19226
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04953170339349
• UDI-Public: 04953170339349
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BF-1TQ180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2010
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR
• Patient Sex: Male
• Patient Weight: 98 KG