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
(b)(6) hospital.The device was returned to olympus for evaluation and the customer's allegation was confirmed.During the evaluation, it was determined that due to a pinhole on bending section cover (a-rubber), water tightness was lost.Additionally, the evaluation revealed the following findings: due to damage on camera section, water tightness was lost; connecting tube had coating peeling.(1mm2 or more); plastic distal end cover (c-cover) had a crack; adhesive on bending section cover (a-rubber) had a chip; connecting tube had a wrinkle; due to wear of angle wire, bending angle in the upward direction did not meet the standard value; due to dent/damage on channel-tube, forceps could not be inserted smoothly; due to damage on channel-tube, channel cleaning brush could not be inserted smoothly; image guide (ig) bundle had a stain; third party repair had been performed; connecting tube had a buckling; and scratches were found on multiple components of the device.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 8 years since the subject device was manufactured.Based on the results of the investigation, the phenomenon was attributed due to stress of repeated use, external factors, or handling.The root cause of this event was unable to be identified.The instruction manual operation manual ¿chapter 3 preparation and inspection, 3.6 inspection of the endoscope¿ describes the following warning: inspect the external surface of the entire insertion section including the bending section and the distal end for dents, bulges, swelling, scratches, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities.Holding the control section with one hand, carefully run your other hand back and forth over the entire length of the insertion section (see figure 3.23).Confirm that no objects or metallic wire protrudes from the insertion section.Also, confirm that the insertion tube is not abnormally rigid.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The customer reported to olympus the airway mobilescope exhibited a leak due to pinholes in the bending rubber (the metal was not sticking out).There were no reports of patient harm or impact associated with this event.During testing and inspection of the returned device revealed that the coating of the scope insertion guide serpentine was peeling off.(1mm2 or more).This had been attributed due to stress of repeated use, deterioration, external factors, or handling.This medical device report (mdr) is being submitted to capture the reportable malfunction found during device evaluation.

• 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17094836
• Report Number: 9610595-2023-08637
• Device Sequence Number: 1868563
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/08/2023

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: 05/10/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2010
• 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