MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. AIRWAY MOBILESCOPE

Model Number	MAF-GM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypoxia (1918); Unspecified Heart Problem (4454)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report has not been returned to olympus for evaluation, therefore physical evaluation of the complaint device could not be performed.The device history record (dhr) for the complaint device(s) could not be performed since no serial number/lot number was provided, however olympus does not ship and device that does not meet all design/safety specifications.Conclusion.The definitive cause of the reported events could not be established.This study's aim was to determine the incidence, management, and outcomes of patients with predicted difficult airways in the ed emergency department.There was no report of any olympus device malfunction.His event has been reported by the importer on mdr# 2951238 - 2021 - 00298.
Event or Problem Description
It is reported in the literature article titled "management of patients with predicted difficult airways in an academic emergency department ", two of seven patients from the awake group had airway intubation performed using olympus maf-gm.Five patients from this group experienced adverse events (hypoxia-2, dysrhythmia-2, and peri-intubation arrest-1).There is no specific information available to clarify which (if any) of the five patients experiencing an adverse event were intubated using the maf-gm.It is reported that all patients in this study were predicted to have difficult airways to intubate.It is also reported that no patient in this study required surgical airway intervention.This report is being submitted to report the potential that an olympus device could have caused or contributed to an adverse event in either of the two patients that were intubated using the maf-gm.There is no report that the maf-gm malfunctioned in any way.

• Brand Name: AIRWAY MOBILESCOPE
• Common Device Name: AIRWAY MOBILESCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11424171
• Report Number: 8010047-2021-03377
• Device Sequence Number: 16885348
• Product Code: EOQ
• UDI-Device Identifier: 04953170340369
• UDI-Public: 04953170340369
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K082720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,literatur
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: MAF-GM
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 03/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other