MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. AIRWAY MOBILESCOPE

Model Number MAF-GM2

Device Problems Device Reprocessing Problem (1091); Peeled/Delaminated (1454)

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

Event Type  malfunction  

Event Description

The customer reported the bending section cover of the airway mobilescope was defective.There was no reported patient harm or impact due to this event.During device evaluation at olympus, it was found the complaint was confirmed and the connecting tube coating was peeled.The report is being submitted due to the peeled coating found during evaluation.

Manufacturer Narrative

Attempts to retrieve additional information from the customer are in progress.The device was returned and evaluated by olympus.In addition to the findings in b5, evaluation found water tightness was lost due to a pinhole on the connecting and instrument tubes, the bending section cover adhesive was chipped, the connecting tube was wrinkled, the bending angle in the up direction did not meet the standard value due to wear of the angle wire, the control unit had corrosion due to water leakage, the battery card cover was sticky, the image guide bundle was stained, the camera section did not rotate smoothly due to damage, and the connecting tube was dented and buckled.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 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 likely cause of the reported event is due to stress of repeated use, external factors, or handling of the device.However, the root cause of the reported event is unable to be determined.If additional information becomes available, this report will be supplemented accordingly.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to provide additional information inadvertently missed on supplemental report.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Based on the results of the investigation for 'insufficient reprocessing or inappropriate scope was used for the next inspection', the customer confirmed that inserting a cleaning brush was usually unimplemented, therefore, the device failed to meet specifications.The event can be prevented by following the instructions for use (ifu) which state: instructions, reprocessing manual chapter 5 ¿reprocessing the endoscope (and related reprocessing accessories)¿ section 5.5 ¿manually cleaning the endoscope and accessories¿.Olympus will continue to monitor field performance for this device.

Event Description

Further follow-up with the customer confirmed that the cleaning brush was not inserted on a daily basis during manual cleaning causing insufficient reprocessing.

• Brand Name: AIRWAY MOBILESCOPE
• Type of Device: AIRWAY MOBILESCOPE
• 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: 16596864
• MDR Text Key: 312283205
• Report Number: 9610595-2023-04888
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04953170407208
• UDI-Public: 04953170407208
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K201300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAF-GM2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2021
• 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