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.The customer's report was confirmed, the water tightness was lost due to a pinhole on the bending section cover.In addition to the malfunction reported in section b5, the following findings were discovered; the water tightness was lost due to a damage on camera section, the bending angle in up direction did not meet the standard value due to wear of angle wire, the forceps could not be inserted smoothly due to a dent on the channel tube, the channel cleaning brush could not be inserted smoothly due to a dent on channel tube, the image guide bundle had a stain, the connecting tube had buckling, and the connecting tube had a scratch.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 leakage from the insertion section.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was found: the connecting tube had coating peeling (1 to 2 or more millimeters).There were no reports of patient harm.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 connecting tube was caused by stress of repeated use, external factors, or handling of the device.¿instructions chapter 3 ¿preparation and inspection¿ section 3.6 ¿inspection of the endoscope¿ describes how to inspect for the subject event.·dhr [whether the subject device was manufactured in accordance with specifications] dhr of the subject device was reviewed and it was confirmed that the device was shipped in conformity with specifications.[whether non-conformity device associated with the subject device has been identified internally] the subject device was free from non-conformity in manufacturing.¿ 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: 18315640
• Report Number: 9610595-2023-19421
• Device Sequence Number: 17838611
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2024

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: 11/22/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2023
• Supplement Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2012
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown