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

Model Number	MAF-GM2
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
This is an olympus loaner device.During maintenance inspection of the device, it was observed that the metal receiver of the forceps mouthpiece was detached.There is no patient involvement.
Additional Manufacturer Narrative
The device is returned and an evaluation completed for it.The user¿s complaint was confirmed.Upon inspection of the device, it was observed that the metal receiver of the forceps mouthpiece was detached.This is attributed to physical stress.Other observations for the device are insufficient angle and noise in camera unit rotation.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.
Additional Manufacturer Narrative
The become aware date (g3) that was corrected to sep 12, 2022, is being reverted back to sep 25, 2022, that was submitted with the initial mdr.The become aware date of sep 25, 2022, is correct.This supplemental report is being submitted to provide this information.
Additional Manufacturer Narrative
There is more information on the device evaluation.Correction is being made to the become aware date (g3) of the initial mdr.This supplemental report is being submitted to provide this information.The g3 value of the initial mdr should be sep 12, 2022, and not sep 25, 2022.Device history record review indicates that the device was manufactured and tested in accordance with all applicable procedures and met all final product release criteria at the time of shipping.Per the latest repair history the device distal end insertion unit was replaced on july 15, 2022.The root cause of the event cannot be conclusively determined.It is likely that the defect was caused by stress of repeated use, external factors, or handling.

• Brand Name: AIRWAY MOBILESCOPE
• Common Device Name: AIRWAY MOBILESCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15638960
• Report Number: 9610595-2022-03112
• Device Sequence Number: 12229389
• Product Code: EOQ
• UDI-Device Identifier: 04953170407208
• UDI-Public: 04953170407208
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K201300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/13/2022

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
• Operator of Device: Other
• Device Model Number: MAF-GM2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2022
• Supplement Date Received by Manufacturer: 10/24/2022; 11/25/2022
• Initial Report FDA Received Date: 10/20/2022
• Supplement Report FDA Received Date: 11/18/2022; 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown