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

Model Number BF-P180

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

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

Event Type  malfunction  

Event Description

The evis exera ii bronchovideoscope was returned with no information.There was no reported patient harm or impact due to this event.During device evaluation at olympus, it was found the image was black and bending section cover was missing.The report is being submitted due to no image and missing cover found during evaluation.

Manufacturer Narrative

The device was returned and evaluated by olympus.In addition to the findings, evaluation found the distal end cover was chipped, dented, and scratched, the bending section cover glue was lifted, the objective and light guide lenses were cracked, the insertion tube was dented, the light guide tube was dented, the scope connector was scratched, the light guide prong and mount were loose, angulation was reduced, and the seal was peeled.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's 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 of the blank image was an internal charge-coupled device (ccd) unit and/or circuit board was damaged by stress on the device (distal end, insertion section, universal cord, scope connector.Damage to the adhesive was due to stress of the device.The event can be prevented by following the instructions for use which state: ¿ifu (operation manual) sates as follows: important information ¿ please read before use: warnings and cautions: do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector 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.Important information ¿ please read before use: precaution for disappeared or frozen endoscopic image: do not bend, hit, or twist the insertion section, control section, universal cord, and endoscope connector.The endoscope may be damaged and water leaks and/or breakage of internal parts like the ccd cable can 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: 16093980
• MDR Text Key: 308201002
• Report Number: 9610595-2023-00104
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04953170308192
• UDI-Public: 04953170308192
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BF-P180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2022
• Initial Date FDA Received: 01/04/2023
• Supplement Dates Manufacturer Received: 03/22/2023
• Supplement Dates FDA Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2010
• 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