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

Model Number	MAF-TM
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation.In addition to the reportable malfunction documented in b5, the evaluation findings are as follows: the camera section, the up/down angulation lever plate, the grip and the control unit were scratched; the connecting tube had a dent; the adhesive on bending section cover had a chip; the bending section cover had discoloration; the displayed image was not bright enough due to the damage on liquid crystal display(lcd)monitor; due to deformation of the card slot, xd picture card could not be inserted or pulled out smoothly; due to a dent on the channel tube, the channel cleaning brush could not inserted smoothly; due to a dent on the channel tube, the forceps could not be inserted smoothly; due to damage on the control section, the angulation lever did not move smoothly; due to a damage on the camera section, water tightness was lost and due to wear of the angle wire, the bending angle in up direction did not meet the standard value.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 or Problem Description
The customer reported to olympus, the airway mobilescope had an image defect, was inoperable and separating.There were no reports of patient harm or impact associated with this event.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was found: the image guide tube coat was peeling.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
Additional 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 peeling image guide tube coat was caused by stress of repeated use, external factors, or handling.Olympus will continue to monitor field performance for this device.

• 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 (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: 18451789
• Report Number: 9610595-2024-00286
• Device Sequence Number: 7566968
• Product Code: EOQ
• UDI-Device Identifier: 04953170288630
• UDI-Public: 04953170288630
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2024

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: Health Professional
• Device Model Number: MAF-TM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/25/2023
• Supplement Date Received by Manufacturer: 01/17/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2010
• 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